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.
(Technical) University/academy degree in Biological Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.