What are the responsibilities and job description for the QA Associate I - Operations position at PCI Pharma Services?
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.
What You'll Do
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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.
What You'll Do
- 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
- 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
- ASQ certification
- Exposure to Lean/Operational Excellence methodologies
- Experience supporting commercial or late-stage clinical GMP operations
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Qa Associate I - Ops
PCI WI Lyophilization Services Madison -
Madison, WI
