Conduct audits at CMO, testing, packaging, and warehouse/distribution operations. Responsible for day-to-day interactions with contract facilities. Ensure GMP documentation of activities at contract facilities. Conduct investigations into Good
Manufacturing Practice (GMP) related issues or problems associated with audits, batch records, and complaints. Approve manufacturing and testing deviations and investigations into out-of-specification results.
Review and approve batch and test records. Review documentation for tech transfer and validation of analytical methods and manufacturing processes. Conduct internal and external audits.
Maintains culture of teamwork, cooperation and continuous improvement. Other duties as assigned. Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor's Degree or higher in Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline. Minimum of 4 years experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industries. Good
Manufacturing Practice experience, or experience in other regulated industry. Excellent communication skills both oral and written. Experience with supporting product inspections from global Regulatory Authorities is required. Experience with pre-
approval inspections and bringing products to commercialization is required Effectively represent Quality Assurance, both internally and externally. Experience in routine office software packages and specialized software applications as appropriate.
LICENSES/CERTIFICATIONS: ASQ Certified Auditor required Six Sigma Greenbelt Certification preferred