Piper Health & Sciences is seeking a QA Document Control Analyst to join a leading biopharmaceutical company in the Lansing, MI area. The ideal candidate will have strong attention to detail, experience with document control systems, and a solid understanding of GMP (Good Manufacturing Practices).
Responsibilities for the QA Document Control Analyst include:
- Maintain and manage document control systems, ensuring accuracy, compliance, and accessibility.
- Review, approve, and archive quality assurance documents, including SOPs, batch records, and validation reports.
- Ensure compliance with FDA, GMP/GDP/GxP, and other regulatory requirements related to document control.
- Coordinate document revisions, approvals, and distribution within the organization.
- Support internal and external audits by providing necessary documentation and records.
- Collaborate with QA, manufacturing, and regulatory teams to ensure proper documentation practices.
- Identify opportunities for process improvements in document management and control.
Qualifications for the QA Document Control Analyst include:
- Minimum of a High School Diploma/GED is required. Bachelor’s degree in a relevant field (e.g., Life Sciences, Biotechnology) is preferred.
- 0-2+ years of experience within a biopharmaceutical or regulated cGMP manufacturing environment.
- Strong knowledge of GMP, FDA regulations, and quality assurance principles is preferred.
- Proficiency in document management systems and Microsoft Office Suite is preferred.
Compensation for the QA Document Control Analyst includes:
- Salary range: approximately $24.00 - $29.00 hourly, commensurate with experience
- Comprehensive Benefits: Cigna Medical/Dental/Vision, ADP 401k, STD, LTD, Paid sick leave as required by law
This job is open for applications on 5/28/2025. Applications will be accepted at least 30 days from the posting date.
Quality assurance, qa, document control, qa/dc, gmp, cgmp, gdp, good manufacturing practices, good documentation practices, gxp, qa doc control, life sciences, biotechnology, biopharma, pharmaceutical, manufacturing, vaccine, drug, cmo, cdmo, entry level qa
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