Senior Quality Assurance Specialist

4 weeks ago


Signal Hill, California, United States Sapta Global Inc Full time
Job Description

Sapta Global Inc is seeking a Senior Quality Assurance Specialist to provide quality oversight to the Contract Manufacturing Organization (CMO) with the ability to be on site to support Quality Reviews and QA Shop Floor manufacturing support.

The ideal candidate will have a BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company. Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company is required.

The Senior Quality Assurance Specialist will be responsible for providing oversight for CMO Batch Production Records, reviewing executed Batch Records, GMP documents, and preparing documentation for product release/disposition. The candidate will also assist with Document Control and other QA functions, coordinate and assist in timely review of documentation associated with manufacturing at CMO site, and assist with preparation for FDA and other regulatory agency audits and inspections.

The successful candidate will have excellent communication and interpersonal skills, with the ability to work effectively with other site groups and manufacturing teams to implement business objectives. The ideal candidate will be detail-oriented and able to quickly detect errors within documentation.

Responsibilities:

  • Provides oversight for CMO Batch Production Records.
  • Reviews executed Batch Records, GMP documents, and prepares documentation for product release/disposition.
  • Assists with Document Control and other QA functions.
  • Coordinates and assists in timely review of documentation associated with manufacturing at CMO site.
  • Assists with preparation for FDA and other regulatory agency audits and inspections.
  • Gives guidance to CMO as needed and ensures CMO is compliant with Client Quality standards.
  • Ensures that all audit items are resolved.
  • Supports site for Inspection.

Qualifications:

  • BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
  • Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company.
  • Fluent in English language.
  • Ability to work effectively with other site groups and manufacturing teams to implement business objectives.
  • Detail-oriented and able to quickly detect errors within documentation.


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