Quality Control Compliance/IPC Specialist

The Specialist Compliance - In-Process Control (IPC) ensures compliant execution of quality control operations related to production start-up, in-process sampling, documentation, and change management. The role supports Data Integrity, regulatory compliance, and safety in the QC environment, contributing to the timely release of products and continuous improvement.
Key Responsibilities:

• Ensure Data Integrity during IPC checks at production and packaging operations start-up by verifying compliance with procedures and good manufacturing practices.
• Perform sampling of bulk, semi-finished, and finished products, as well as stability and retained samples, in alignment with GMP and site procedures.
• Conduct sampling for validation studies such as Holding Time and cleaning verification.
• Label compliant batches and prepare documentation for release to the distribution center.
• Identify and escalate non-conformities observed during production or IPC activities to appropriate hierarchy.
• Participate in QC investigations including LIRs, RAACs, QARs, and ERs, providing input and supporting root cause analysis.
• Contribute to annual trending reports and quality risk assessments
• Support continuous improvement initiatives (QC & IMEX) and ensure proper completion and review of QC logbooks for traceability.
• Create, revise, and archive QC documentation in line with document control procedures and ensure availability for inspection readiness.
• Manage "Official Print" and document reconciliation in QC and microbiology lab
• Implement and monitor QC change controls, ensuring timely execution of actions and proper documentation of changes.
• Ensure EHS compliance within the QC area by adhering to safety requirement and promoting a safe work environment.

Here Is What You Need (Minimum Requirements):

• BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience
• Excellent written and verbal communication skills
• High degree of computer literacy, particularly in Microsoft Office Applications
• Experience in prior Quality Documentation assignments
• Ability to design and author documents
• Proficiency in technical writing, creating electronic documentation, and utilizing electronic document management systems
• Great knowledge in good manufacturing practices and good laboratory practices

Bonus Points If You Have (Preferred Requirements):

• Previous Experience in QC laboratory or Manufacturing of drugs
• Knowledge of GMP regulations and compliance requirements

This position requires flexibility in working hours, with the ability to periodically adapt and switch between different shifts.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control