Capital Associated Industries, Inc.
  • Durham, NC, USA
  • Full Time

SCOPE:  This individual will utilize developed, internal quality systems, procedures, and practices to cGMP manufacturing of a cellular based product under a cGMP compliant environment. Will assist in the development of new and maintaining existing systems.                        

RESPONSIBILITIES:

  • Assist with QA review of GMP documentation, including Item Specifications, SOPs, production records, validation protocols and reports.
  • Initiate and approve Deviations, CAPAs, Change Request and non-conforming reports.
  • Review executed batch records and participate in the disposition of Clinical Trials Materials (CTMs) including review of all associated documentation.
  • Assist in Material Review Board (MRB) meetings and Management Reviews preparation.
  • Provide QA review and release of incoming raw materials and serve as a resource in resolving discrepancies.
  • Provide QA review and oversight for product shipments.
  • Review and organize the archiving of executed batch records.
  • Review QC results.
  • Conduct internal and external audits as required.
  • Organize initiation, receipt, and review of Vendor Surveys.
  • Other duties as required

 QUALIFICATIONS:

  • Prefer Bachelor's or Master's degree in a scientific discipline or equivalent
  • A minimum of five years industrial cGMP experience in an FDA regulated Biopharmaceutical environment with 3+ years QA experience
  • Strong writing and verbal communication skills
  • Strong computer skills (Word, Excel, PowerPoint, etc.)
  • Must have experience auditing to cGMP standards and writing and maintaining controlled documents
  • Strong interpersonal communication skills
  • Demonstrated initiative and attention to detail
  • Demonstrated ability to multitask and meet deadlines
  • Ability and willingness to be regularly, predictably and reliably at work
  • Willingness to travel for external audits 

PHYSICAL DEMANDS:

Work is primarily sedentary in nature.

Capital Associated Industries, Inc.
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