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We're looking for a QA Documentation Specialist
, working in Pharmaceuticals and Medical Products
industry in 220 East Hanover Avenue, Morris Plains, New Jersey, 07950, United States
- Maintains and follows CGT procedures for MBR creation, issuance, receipt, reconciliation, filing and archiving.
- Prints and issues batch records, in-process labels, and final product labels to support operations.
- Issues labeling/tags for Apheresis from LKPK Traveler through Packaging.
- Enters/maintains information accurately in systems/applications (e.g. SAP, LIMS, Cell Chain, etc.) as necessary to support operations and overall life cycle of documents.
- Supports document control room and GxP document lifecycle management activities such as filing, archiving, providing execution copies, etc.
- Supports validation/qualification activities as needed (e.g. labeling associated with Cell Chain).
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Must have direct experience in Document Control function Experience with Quality Management Systems, Quality Compliance or Quality Assurance
- Knowledge of GMP manufacturing operations (manufacturing, packaging, facilities, critical systems, automation, validation, etc.) preferred
- Ability to follow and apply GDocP and cGMP principals
- Ability to communicate clearly (written and verbal) and in an engaging manner with colleagues of various levels of experience and management
- Comfortable working in a matrix environment and communicating with site, global, and external functions as needed
- Ability to perform tasks that require standing or sitting for long periods of time
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?