Job Description

Job Responsibilities:

• Support QC functions related to GXP activities (e.g., cGMP manufacture of clinical and commercial active pharmaceutical ingredients)
• Manage laboratories that perform finished product testing of clinical and commercial materials
• Streamline current processes and procedures to provide consistent, timely performance
• Review and approve certificates of analysis received from contract laboratories
• Review and approve deviations related to QC activities
• Review OOS and OOT Investigations
• Support audits of contract laboratories in cooperation with Quality Assurance
• Review raw materials, in process and finished product specifications (purchasing, release and stability)
• Perform trend analysis of testing data to establish purchasing and release specifications for in process and finished product
• Assist with preparation and review of regulatory filings
• Assist with preparation, review and approval of APRs
• Create, edit, review and approve SOPs

Qualifications:

Minimum of 7 years of experience in the pharmaceutical industry and quality systems

Minimum of 3 years of QC laboratory experience

Bachelor's Degree in life sciences, preferably chemistry

Experience in regulated manufacturing environments including regulatory authority inspections

Strong written and verbal communication skills

Demonstrated experience in structured process improvement

Experience performing oversight and audits of laboratories

Experience reviewing and approving raw data, test results and certificates of analysis for raw materials, drug product intermediates and final product

Experience reviewing and approving method transfer and method validation protocols and reports