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QA Documentation Specialist

Edison-New Brunswick Metro Area, NJ

Post Date: 05/10/2018 Job ID: JN -052018-21558 Job Type: Scientific
  • QA Specialist - 2nd Shift and one weekend day.
    BS in Biological Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.
    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.

    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.
    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
    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.
    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.

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