Job Title: Documentation Assistant, Document Control
Location: Branchburg, NJ (100% Onsite)
Pay: $27.88
Duration: 18 months
Shift: 8-4:30 pm Monday - Friday
Must Haves:
BA/BS degree or equivalent experience is preferred.
1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required.
Responsibilities:
Assist in the distribution, reconciliation, labeling and filing of GMP documentation. Update and maintain document tracking databases and archival systems. Assist in Documentation Audit programs for GMP documents. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation. Some physical movement of document files/boxes is required; must be able to lift 30 pounds
Distribute approved documentation to appropriate personnel, track receipt of documentation, reconciliation and maintain distribution matrices.
Assist in the maintenance of hard copy and electronic document files.
Label and code files for storage in on-site Documentation Centers.
Assist in the administration of the company GMP Records Retention Policy, including document imaging and preparing documents for shipment to off-site storage.
Data Entry of batch record data into qualified database.
Initiate and track periodic Documentation Binder Audits to assure documentation in the field is current and complete.
Ensure ethics and compliance commitment at all times. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.