QA Documentation Control Associate - GMP, batch records in Morris Plains, NJ at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Responsibilities:

  • 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

Qualifications:

  • Bachelor's degree in Biological Sciences, Chemistry, Pharmacy, Engineering or equivalent education/experience in Pharmaceuticals desired
  • 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

**For immediate consideration, please email your updated resume to bfreeman@apexlifesciences.com with 'QA Documentation Associate NJ' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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