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QA Documentation Specialist

Edison-New Brunswick Metro Area, NJ

Posted: 03/04/2019 Job Type: Scientific Job Number: JN -032019-23832
  • 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.

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