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QA Documentation Specialist

Job Attributes

Job Id:

21725

Job Category:

Clinical & Life Sciences

Job Location:

Boothwyn, PA  19013

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is looking for an QA Documentation Specialist to be accountable for the implementation and maintenance of an electronic document repository for a growing Pharmaceutical Company in Boothwyn, PA.

Responsibilities for the QA Documentation Specialist include:

  • Implement and Maintain the EDR within GMP/GDP
  • Assist with issuance of tracking numbers for Quality Systems (Change Controls, Deviations, CAPA, Document numbering, Logbook Issuance, etc.)
  • Review of documents created by others for accuracy, clarity, formatting, and compliance to cGMP/GDP requirements
  • Type new and revised Standard Operating Procedures (SOPs), raw materials, packaging materials, drug product specifications, testing procedures, forms, Certificates of Analysis (C of A’s)
  • Create document control requests to revise/update documents
  • Assist with issuance of tracking numbers for Quality Systems (Change Controls, Deviations, CAPA, Document numbering, Logbook Issuance, etc.) 

Qualifications for the QA Documentation Specialist include:

  • Bachelor’s degree in Biology or similar discipline
  • 3+ years of experience working with QA or QC
  • 3+ years of documentation experience within a GMP regulated facility
  • Experience with electronic document repositories and LIMS

Compensation for the QA Documentation Specialist include:

  • Salary Range: $60,000 - $75,000
  • Full benefits package

Keywords:

Quality Assurance, QA, Documentation, Specialist, ERD, Electronic Documentation Repository, Pharmaceutical, Trackwise, GMP, GDP, Pennsylvania, PA, Boothwyn, CAPA, SOP, Validation Documentation, Batch Records, LMS

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Job Id:

21725

Job Category:

Clinical & Life Sciences

Job Location:

Boothwyn, PA  19013

Security Clearance:

No Clearance

Business Unit:

Piper Companies