QA Associate I - Operations

PCI Pharma Services • Madison, WI

7d

About The Position

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. Step Into Quality. Start Your Career with Purpose. Are you eager to build your career in pharmaceutical manufacturing while making a meaningful impact on product quality and patient safety? Join us at PCI as a Quality Associate I – Operations , where you’ll be on the front lines of GMP production—supporting real-time quality oversight, solving problems as they arise, and ensuring that every product meets the highest standards of safety, efficacy, and compliance. This is an ideal role for early-career professionals passionate about science, quality, and continuous improvement. You'll receive hands-on training, mentorship, and exposure to industry best practices while working in a fast-paced, collaborative environment.

Requirements

• Bachelor’s degree in a relevant scientific field (preferred)
• 0–2 years of experience in the pharmaceutical or biotech industry
• 1+ years of experience in QA Operations (preferred)
• Understanding of GMP regulations (21 CFR 210/211/820); exposure to ICH guidelines and risk tools (FMEA, HACCP, ICH Q9) a plus
• Strong organizational and technical writing skills, with attention to detail
• Familiarity with Microsoft Word, Excel, and Outlook
• Ability to manage multiple tasks and communicate effectively across teams
• Self-starter mindset with the ability to work independently and escalate issues appropriately
• Flexible and adaptable to fast-paced, evolving environments

Nice To Haves

• ASQ certification
• Exposure to Lean/Operational Excellence methodologies
• Experience supporting commercial or late-stage clinical GMP operations

Responsibilities

• Provide real-time QA support on the production floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturing
• Perform in-process reviews of executed batch records and documentation for completeness and accuracy
• Participate in lot disposition and review of drug product and intermediates
• Act as a first responder to quality issues, documenting investigations and supporting immediate corrective actions
• Conduct Acceptable Quality Limit (AQL) visual inspections of drug product
• Support deviation documentation, root cause investigations (using tools like 5 Whys, Fishbone), and CAPA processes
• Collaborate across departments and represent QA during manufacturing activities and process improvements
• Contribute to SOP revisions, quality initiatives, and regulatory readiness

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level