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Cranbury

120 đź’Ľ Trabajos en Cranbury, NJ

Sr. Director, Global Medical Operations

nuevoabout 16 hours ago
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Sr. Director, Global Medical Operations Location US-Cranbury, NJ Requisition ID 1554 of openings 1 Sr. Director, Global Medical Operations Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. This key role serves to support the Global Medical Affairs (GMA) team, both International and U.S., providing oversight and implementing and maintaining best practices for the Publications (Pubs), Medical Information (MI), and Grants Functions within Medical Affairs. The Senior Director, Global Medical Operations is responsi

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Scientist, Bioassay (Potency), Gene Therapy

nuevo1 day ago
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Scientist, Bioassay (Potency), Gene Therapy Location US-Cranbury, NJ Requisition ID 1556 of openings 1 Scientist, Bioassay (Potency), Gene Therapy Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. The Scientist position will serve as a bench scientist in cell-based potency assays of the analytical development group to support the gene therapy pipeline and other programs. The role will support establishing and will routinely run the potency assays to support characterization, formulation development, process de

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Research Investigator, Analytical Development, Gene Therapy

nuevo1 day ago
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Research Investigator, Analytical Development, Gene Therapy Location US-Cranbury, NJ Requisition ID 1555 of openings 1 Research Investigator, Analytical Development, Gene Therapy Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. This position will serve as a Subject Matter Expert (SME) in the Analytical Development group focusing on qPCR and AUC to support the gene therapy pipeline. The role will establish and routinely run assays to support characterization, process development and manufacturing of gene thera

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Director of Benefits

nuevo2 days ago
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About The Opportunity A recognized pharmaceutical company located in Cranbury, NJ is actively seeking a self-motivated and dynamic human resources professional for a promising opportunity as their new Director of Benefits. In this role, the Director of Benefits will oversee company-wide global benefits plans. Apply today COMPANY DESCRIPTION Pharmaceutical Company JOB DESCRIPTION The Director of Benefits will: Design and implement global benefit programs, processes and practices that are responsive to the company's changing business needs and requirements in each geographic location Serve as a benefits subject matter expert, developing solutions and market based p

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Clinical Trial Manager

nuevo2 days ago
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Clinical Trial Manager Location US-Cranbury, NJ Requisition ID 1510 of openings 1 Clinical Trial Manager The Clinical Trials Manager is responsible for the day-to-day activities associated with managing clinical studies. Working closely with the Associate Director, Clinical Operations and collaborating with colleagues in other functions, the Clinical Trials Manager supports the operational team to ensure excellent operational oversight of clinical studies. The Clinical Trials Manager contributes to and manages the project plans, manages and oversight of vendors, performs tasks during protocol design to final CSR, to produce high-quality study data, adh

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Manager, Clinical Quality Assurance

nuevo2 days ago
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Manager, Clinical Quality Assurance Location US-Cranbury, NJ Requisition ID 1509 of openings 1 Manager, Clinical Quality Assurance The Manager Clinical QA will be responsible for: (i) auditing sponsor processes, trial master files, investigator sites, vendors (e.g., CROs) and systems under the guidance of a senior member of the department, and (ii) ensuring quality activities are performed and documented in compliance with corporate policies and standards, and all applicable global regulations with minimal supervisory oversight. The Manager Clinical QA will be responsible for: Conducting GCP Risk Assessments. Assisting in the development and imp

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Manager, Medical Affairs

nuevo2 days ago
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Manager, Medical Affairs Location US-Cranbury, NJ Requisition ID 1549 of openings 1 Manager, Medical Affairs Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. The Manager, Medical Affairs will provide support for Amicus Medical Affairs focusing on Fabry disease. This individual will facilitate the cross-functional preparation, implementation and facilitation of projects related to HCP engagement activities. The Manager, Medical Affairs will also assist with various project activities, primarily medical advis

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Executive Director, Clinical Research -Gene Therapy

nuevo2 days ago
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Executive Director, Clinical Research -Gene Therapy Location US-Cranbury, NJ Requisition ID 1428 of openings 1 Executive Director, Clinical Research -Gene Therapy The Executive Director, Clinical Research – Gene Therapy, is responsible for leading the generation of the Clinical Development Plans and the clinical trial protocols that will lead to successful submissions of novel Gene Therapy treatments. In this area of Gene Therapy treatments, the Executive Director, Clinical Research will provide insight to the CMO and the VP, Clinical Research and will collaborate with other functions in the Development Organization to optimize the strategy of Amicus Th

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Senior Research Investigator II, Cell Line and Gene Therapy Process Development

nuevo2 days ago
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Senior Research Investigator II, Cell Line and Gene Therapy Process Development Location US-Cranbury, NJ Requisition ID 1495 of openings 1 Senior Research Investigator II, Cell Line and Gene Therapy Process Development The Senior Research Investigator II in Cell Culture Process development will be responsible for cell line development and cell banking and support cell culture process and technology development to a portfolio of early and late stage gene therapies. Responsible for cell line and cell banking for viral vector production Evaluate multiple producer cell line types for various gene therapy programs Oversee manufacturing of MCB/ WCB

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Manager, Product Disposition

nuevo2 days ago
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Manager, Product Disposition Location US-Cranbury, NJ Requisition ID 1516 of openings 1 Manager, Product Disposition Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. Amicus Therapeutics is seeking a Manager, Product Disposition with in depth experience of biologics manufacturing. Reporting to the Associate Director of Product Disposition, the Manager Product Disposition will provide Quality oversight and support to the Technical Operations group for the production of non-clinical, clinical and commercial p

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Senior Accountant

nuevo2 days ago
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Senior Accountant Location US-Cranbury, NJ Requisition ID 1508 of openings 1 Senior Accountant The Senior Accountant will be primarily responsible for supporting the financial close process which includes the consolidation of worldwide financial data. In addition, this position will be responsible for preparing financial account statement analyses and other financial reporting support as needed. This position will report to the Senior Accounting Manager but also work closely with the Financial Planning and Analysis team to support the overall Global Finance objectives, and liaise with business partners across the organization. The ideal candidate wi

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Director, Technical Accounting and Reporting

nuevo2 days ago
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Director, Technical Accounting and Reporting Location US-Cranbury, NJ Requisition ID 1527 of openings 1 Director, Technical Accounting and Reporting Amicus Therapeutics is a global patient-dedicated biotechnology company engaged in the discovery, development and commercialization of a diverse set of novel treatments for patients living with rare metabolic diseases. The cornerstone of the Company’s portfolio is migalastat HCl, an oral precision medicine for people living with Fabry disease who have amenable genetic mutations. Migalastat is currently approved under the trade name GALAFOLD in the European Union, U.S. and Japan, with additional approvals gr

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Senior Director, Global Regulatory Affairs – Gene Therapy

nuevo2 days ago
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Senior Director, Global Regulatory Affairs – Gene Therapy Location US-Cranbury, NJ Requisition ID 1521 of openings 1 Senior Director, Global Regulatory Affairs – Gene Therapy Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. The Senior Director Global Regulatory Affairs – Gene Therapy provides strategic and operational leadership to cross-functional project teams responsible for gene therapy product development. The Senior Director working in collaboration with Science & Research, Program Management, Clini

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Local Class A Truck Driver- Cranbury NJ

nuevo2 days ago
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Truck One, Inc. $1,200 Average Weekly and Home Daily Company Drivers. Locations of openings: (1) Biglerville, PA (2) Hazleton, PA (3) Mt. Carmel, PA (4) Spotswood, NJ Truck One, Inc., in business for over 70 years, continues to stay focused on meeting our customers’ needs and creating long lasting relationships with our drivers. At Truck One We Offer: - Paid Weekly/Direct Deposit - Home Daily - Two Weeks Earned Time Off - Six Paid Holidays - Major Medical Coverage/Vision and Dental - Retirement Contributions - Fast and Easy Orientation - Driver Referral Bonus Program - Fuel Card Provided - PrePass Provided To learn more about driving with us, please complete the quick application to the right and if on a mobile device the application is below.

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QA Documentation Assistant- Cranbury NJ

nuevo3 days ago
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QA Documentation Assistant- Cranbury NJ 08512 SUMMARY: Revise and maintain controlled documents such as SOPs, Forms, Specifications, Monographs, Protocols, etc.

trabajos porJuju.com

CDL Driver - (Any Commercial Class)

nuevo3 days ago
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…Recruiting Drivers For Our Local, Dedicated FedEx Custom Critical Routes Dispatching From Cranbury , NJ . We Offer Full-Time Employee Positions With Steady Work

trabajos porJuju.com

Senior Director, Global Regulatory Affairs

nuevo3 days ago
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Summary of Position The Senior Director Global Regulatory Affairs – Gene Therapy provides strategic and operational leadership to cross-functional project teams responsible for gene therapy product development. The Senior Director working in collaboration with Science & Research, Program Management, Clinical/ Nonclinical Development, Market Research, and Patient Advocacy coordinates the creation and validation of a defined, functionally-integrated, global regulatory strategic plan including regulatory authority interactions required to support key milestones from initiation of clinical development through marketing authorization in target regions and countries as identified. The defined global strategic development plan defines key data requirements supporting key claims driving competitive target labeling for a globally approved gene therapy product upon product launch, including all aspects of market accessibility and reimbursement by CMA and global HTAs. The Sr. Director, working with assigned GRLs for gene therapy programs, coordinates interactions of global Ministries of Health (MoH) to validate the defined global regulatory strategy, and to negotiate agreements and modifications to the defined strategy (as required). Working with program GRLs, the Sr. Director directs multi-functional planning and conduct of regulatory agency meetings and interactions with MoH. The Sr. Director is responsible for updating teams on new developments (competitive, regulatory policy/ guidance, review and/or compliance related topics) as relevant to global gene therapy regulatory product development. Major Activities and Responsibilities The Sr. Director, Global Regulatory Affairs – Gene Therapy is responsible for: Working with Sr. Mgmt, Core Teams, Functional Area Heads, GRLs, key functional SMEs and Project Teams, utilizes experience and regulatory expertise of regulatory requirements in advanced therapeutics to interpret, plan, and communicate global regulatory requirements to ensure completion and corporate objectives related to gene therapy product development programs, including guidance and assistance on resolution of complex program issues. Working in collaboration with Program Management, Science & Research, Clinical/ Nonclinical Development, Market Research, and Patient Advocacy, creation of a defined, functionally-integrated, global regulatory strategic plan including regulatory authority interactions required to support key milestones from initiation of clinical development through marketing authorization in target regions and countries as identified. Working with Program Management, Clinical Research, Market Research, Patient Advocacy coordinate the creation of a program target product profile, which outlines intended key labelling claims to be substantiated with data generated as part of gene therapy development programs. Working with the GRLs and project teams, providing strategic guidance/input throughout all stages of program development, to guide and focus team activities on key data requirements, including timing of data availability, MoH communication, including identification of key risks and mitigation strategies. Working with the GRLs and project teams, provide guidance on content and provide review and approval of regulatory submissions including Request for Designation, Meeting Background Packages, Clinical Trial Applications, and Marketing Applications. Communicates/ Collaborates with other internal and external key stakeholders as appropriate to support corporate quality assurance, pharmacovigilance and other efforts and ensure alignment and communication across functions. Take steps to actively improve interdepartmental communications. Working in collaboration with the Sr. Vice President of GRA, to inform/ advise on the gene therapy program requirements and timelines for the GRA function, including identification and selection of resources (employees and/or contractors) required to meet GRA functional and corporate objectives. In partnership with other regulatory affairs staff, maintains and develops knowledge of global regulatory requirements (e.g. new regulations and laws) that affect the further clinical development and commercialization of assigned products/compounds. Manages, coaches and mentors direct and indirect reports. Performs other tasks and assignments as needed and specified by management. Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations. May have presence on external regulatory committees/trade associations. Qualifications and Background Requirements Advanced degree (MD/PhD/JD/PharmD) highly preferred. Bachelor’s degree in life/health sciences required. Minimum of 10 years in Regulatory Affairs. 12 years pharmaceutical/biotechnology industry experience with technical management experience. Expert knowledge and experience in gene therapy highly desirable. Comprehensive knowledge of applicable regulations. Experience and Skills Experience in interpretation of regulations, guidelines, policy statements, etc. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project. Solid knowledge of GCPs and GLPs. Direct experience in interfacing with relevant regulatory authorities. Foster effective, positive interactions with regulatory agencies, and corporate partners. Ability to lead and influence project teams, committees, etc. to attain group goals. Demonstrate excellent leadership and communication skills. Ability to represent the department in project teams, committees and external meetings. Demonstrate strong organizational skills, including the ability to prioritize personal workload. Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff. Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams. Well organized, detail oriented, effective written and oral communication skills. Supervisory/mentoring experience. Ability to guide, train, supervise and prioritize workload of direct reports if applicable. International regulatory experience preferred. Location This position may be based in both/either at 1 Cedar Brook Drive, Cranbury, NJ, 08512 or 37th & Market Street, Philadelphia, PA. Estimated Travel 10-15%

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QA Documentation Assistant- Cranbury NJ

nuevo4 days ago
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QA Documentation Assistant- Cranbury NJ 08512 SUMMARY: Revise and maintain controlled documents such as SOPs, Forms, Specifications, Monographs, Protocols, etc. Process Document Change Requests. Scan and file all controlled documents. Maintain Documentation Room. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Revise, route, issue, scan, and file controlled documents including SOPs, forms, specifications, test methods, protocols, etc. Coordinate revision, review, and approval of all GMP documents. Responsible for all document control function, including document login, tracking, processing, distributing and archiving all GMP documents. Create, issue and maintain controlled forms and logbooks. Monitor and reconcile all controlled documents. Administer document change control process and maintain document database. Review and process Document Change Requests (DCRs) and Change Control Requests (CCRs) for accuracy. Assign tracking numbers and track DCRs and CCRs through completion. ADDITIONAL RESPONSIBILITIES: Assemble documents required for regulatory submissions Assist in assembling and reviewing documents during regulatory and third party audits. Participates in internal audits and supporting external audits. EDUCATION AND EXPERIENCE: Some college or technical school preferred or equivalent work experience and/or training. Quality professional with three to six months of experience with document control process in pharmaceutical industry JOB PREREQUISITES: Excellent computer skills with working knowledge of MS office, such as Access, Excel, Word, PowerPoint and Adobe Acrobat professional. Well-organized and detailed oriented professional, with strong verbal and written communication skills. Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet deadlines. Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. Occasionally, it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly Services ® As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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Local Class A Truck Driver- Cranbury NJ

nuevo4 days ago
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…of openings: (1) Biglerville, PA (2) Hazleton, PA (3) Mt. Carmel, PA (4) Spotswood, NJ Truck One, Inc., in business for over 70 years, continues to stay focused on

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Vice President - Commercial Lending Officer

nuevo4 days ago
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…Vice President - Commercial Lending Officer 2650 Rte 130 & Dey Road Cranbury , NJ 08512 US Posted: 03/18/19 2019-01-08 2019-04-17 Employment Type: Direct

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Social Media Customer Service Representative

nuevo4 days ago
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…a Social Media Customer Service Representative to work with a growing company in Cranbury , NJ ! This is an excellent opportunity for someone who is proficient

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Regulatory Submissions Manager- Pompe

5 days ago
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Regulatory Submissions Manager- Pompe Location US-Cranbury, NJ Requisition ID 1469 of openings 1 Regulatory Submissions Manager - Pompe The Regulatory Submissions Manager will be responsible for managing regulatory submission projects, reporting to the Associate Director, Regulatory Affairs Project Management. This individual is expected to have strong project management skills, combined with a working knowledge of global regulatory dossier practices and requirements, in order to drive execution of submission content plans through collaboration with cross-functional team members. The Regulatory Submissions Manager will ensure team alignment on submissio

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Associate Director, Pompe Disease, Global Marketing

8 days ago
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Associate Director, Pompe Disease, Global Marketing Location US-Cranbury, NJ Requisition ID 1550 of openings 1 Associate Director, Pompe Disease, Global Marketing Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. The Global Marketing Team is seeking a new team member whose primary focus will be to help drive early planning and pre-commercialization activities for Pompe disease. He/she will lead the new product planning matrix team, refine and validate assumptions about the market opportunity, and over time ini

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Associate Director, Quality Assurance - Gene Therapy

9 days ago
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Associate Director, Quality Assurance - Gene Therapy Location US-Cranbury, NJ Requisition ID 1447 of openings 1 Associate Director, Quality Assurance - Gene Therapy Please Note- Candidates without Gene Therapy specific experience WILL NOT be considered for this role. Amicus Therapeutics is seeking an Associate Director of Gene Therapy (GTx) QA. The incumbent provides Quality Assurance oversight of GTx development, contract manufacturing, and quality control. Specifically, this position will support the areas of Development, Technology Transfer, and manufacturing for new and existing GTx products. The Associate Director of Gene Therapy (GTx) QA p

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Operations Manager - TownePlace Suites - NJ - Central & Shore Points

12 days ago
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Operations Manager - TownePlace Suites by MARRIOTT, South Brunswick / Cranbury Position Details We ... Previous experience with new property openings is aPLUS About us. If you can eat there, drink there ...

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Bilingual Customer Service Representative

12 days ago
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…Service Representative to work at a manufacturing company in Cranbury , NJ .Schedule: Monday-Friday 8:00AM-5:00PMPay Rate: $17.00-$20.00/hourTemp-to-Hire or Direct

trabajos porJuju.com

Accounting Coordinator

14 days ago
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Accounting Coordinator Cranbury , NJ Job descriptionAccounts Payable Coordinator performs various clerical and routine accounting tasks in support of the

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Warehouse LP Auditor Shipping and Receiving P | Cranbury NJ

18 days ago
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Cranbury, NJ Hours: 1st shift: M-F Flexible hours Temp to perm position * Quick Apply - Text "LPCranbury" to 732.251.2244 to get address or book an appointment for our open house (appointments are ...

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Warehouse Associate Pick Pack in Cranbury NJ

23 days ago
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Cornerstone Staffing has a new client in Cranbury, NJ that is hiring for warehouse associate positions! If interested in the job below please email [email protected] with your resume or call ...

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QA Documentation Assistant- Cranbury NJ

24 days ago
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QA Documentation Assistant- Cranbury NJ 08512 SUMMARY: Revise and maintain controlled documents such as SOPs, Forms, Specifications, Monographs, Protocols, etc. Process Document Change Requests. Scan ...

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Sales Coordinator

about 1 month ago
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A central NJ Material Handling Company with offices in Cranbury, NJ and Union, NJ has an opportunity for a Sales Coordinator in our fast paced and growing Sales department. This candidate must ...

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Director, Clinical Research – Pompe Disease

about 1 month ago
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Director, Clinical Research – Pompe Disease Location US-Cranbury, NJ Requisition ID 1405 of openings 1 Director, Clinical Research – Pompe Disease The Sr. Dir./Director, Clinical Research, Pompe will be responsible for ensuring the best possible global development strategy and execution of the Pompe program in Amicus’ pipeline leading to successful submissions to Regulatory Authorities. This position will collaborate with multiple individuals within Amicus, most notably in Clinical Operations, Regulatory Affairs, Discovery Research, Program Management and Medical Affairs to execute this strategy. This position will have the experience, flexibility and m

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Associate Director, Fabry Global Marketing

about 1 month ago
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Associate Director, Fabry Global Marketing Location US-Cranbury, NJ Requisition ID 1513 of openings 1 Associate Director, Fabry Global Marketing Amicus Therapeutics is a biopharmaceutical company at the forefront of developing next-generation medicines to treat a range of rare and orphan diseases, with a focus on improved therapies for Lysosomal Storage Disorders. The Fabry franchise represents the most advanced program at Amicus, led by a novel precision medicine, Galafold (migalastat), for patients with amenable mutations. Galafold is well on its way to becoming a global brand. Galafold is approved in the EU, Switzerland, Australia, Israel, Japan, Can

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Director, Clinical Research - Gene Therapy

about 1 month ago
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Director, Clinical Research - Gene Therapy Location US-Cranbury, NJ Requisition ID 1429 of openings 1 Director, Clinical Research - Gene Therapy The Director, Clinical Research – Gene Therapy, is expected to have a key role in the generation of the Clinical Development Plan and to elaborate the protocols that will lead to a successful submission of novel Gene Therapy diseases. In this area of Gene Therapy treatments of lysosomal storage diseases, the Director, Clinical Research will collaborate with peers in the Development Organization to optimize the strategy of Amicus Therapeutics and to implement, execute, analyze and report the clinical studies int

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Sales Representative - Landsberg Orora New Jersey

about 2 months ago
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Cranbury, NJ * FLSA Status: Exempt Landsberg Orora started in 1947, with the philosophy that everything begins and ends with the customer. Today, with locations across North America, Europe and Asia ...

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Distribution Associate - Cranbury NJ -11:30am start time

11 months ago
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* Monday through Friday -- no weekends * Weekly Pay! * Starting pay $14.70/hr An advanced-level distribution role that requires frequent material handling equipment use. This role utilizes cutting edge ...

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