Qa Associate I - Ops

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

About the role

The Quality Associate I - Operations is the first of two levels within the QA Associate job family. The associate I provides real-time QA support on the floor for GMP Manufacturing of drug product. The work scope includes floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review, and supporting other QA functions as needed. Real-time continuous monitoring of manufacturing-related systems and processes ensures compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase-appropriate GMP manufacture of drug products.

This is a second-shift position located in Madison, Wisconsin, reporting to the Quality Assurance Operations Supervisor.

Responsibilities

• Perform QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.
• Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy, and compliance.
• Support the evaluation and lot disposition of intermediates, finish bulk drug substance, and drug product.
• Act as first responder for on-the-floor quality issues in a timely manner, documenting all events/investigations and required immediate corrective actions.
• Participate in root cause analysis using methodologies such as fishbone, 5 whys, etc.
• Act as QA reviewer for deviations and CAPA issuance, with limited approval authority as designated by QA Management.
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product.
• Participate in SOP revision as it pertains to process improvements.
• Participate in site quality and process improvement initiatives.
• Represent QA on project teams and provide the QA perspective as necessary.
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.

Requirements

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 0-2 years of pharmaceutical or biotech industry experience.
• 1+ years of experience in a QA Operations role supporting late-stage clinical and/or commercial production preferred.
• Exposure to RCA, technical writing, and working with quality-related investigations.
• Exposure to lean operational excellence highly desirable.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH.
• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks.
• Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred.
• ASQ certification preferred.