Quality Associate I – Operations Job at PCI Pharma Services (Madison)

Job Description

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.

Job Responsibility

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

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)
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 have

ASQ certification
Exposure to Lean/Operational Excellence methodologies
Experience supporting commercial or late-stage clinical GMP operations
Exposure to ICH guidelines and risk tools (FMEA, HACCP, ICH Q9)

PCI Pharma Services - All Job Offers

Select Country

Quality Associate I – Operations

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?

Quality Associate I – Operations

Patient Safety Associate I (Drug Safety Associate I)

Sr. Associate I, Quality Control

Associate I, Quality Assurance

Sr. Associate I, Quality Control

Sr. Associate I, Quality Control

Quality Operations Associate

Quality Lab Associate I - Environmental Monitoring

Quality Lab Associate I - Environmental Monitoring

Our AI answers in your language