QA Associate I - Operations

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

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 You Bring

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

Preferred but Not Required

ASQ certification

Exposure to Lean / Operational Excellence methodologies

Experience supporting commercial or late-stage clinical GMP operations

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ()

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer / Vet / Disabled