QA Documentation Specialist
Edison-New Brunswick Metro Area, NJ
- Maintain and follow CGT procedures for MBR creation, issuance, receipt, reconciliation, filing and archiving.
- Print and issue batch records, in-process labels, and final product labels to support operations.
- Issue labeling/tags for Apheresis from LKPK Traveler through Packaging,
- Enter/maintain information accurately in systems/applications (e.g. SAP, LIMS, Cell Chain, etc.) as necessary to support operations and overall life cycle of documents.
- Support document control room and GxP document lifecycle management activities such as filing, archiving, providing execution copies, etc.
- Support validation/qualification activities as needed (e.g. labeling associated with Cell Chain).
- Implement and ensure adherence of appropriate regulations and quality standards.
- Support regulatory filings as needed.
- Complete job-related training along with GMP, safety, and Ethics & Compliance course requirements.
- Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
- Provide documentation for self-inspections, internal/external audits and health authority inspections. Interact with health authority, partner and supplier auditors/inspectors as needed.
- Enter/maintain information accurately following GDocP to support operations and overall life cycle of documents and records.
- Shifts covering daytime / evening and one or both weekend days (minimum 1 weekend day) as required to support operations.
- 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.
University/academy degree in Biological Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.