Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
SECOND SHIFT
Position Title: QA Associate I - Operations
Location: Madison, Wisconsin
Department: Quality Assurance
Reporting To: Quality Assurance Operations Supervisor
Responsible For (Staff): No
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 to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products
ESSENTIAL DUTIES AND 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, documentation of all events/investigations and required immediate corrective actions
- May 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 represent 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
QUALIFICATIONS:
Required:
- Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 0-2 years of pharmaceutical or biotech industry experience with 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 operation 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
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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.
Skills Required
- 0-2 years pharmaceutical or biotech industry experience (minimum)
- Experience in QA Operations supporting late-stage clinical and/or commercial production (1+ years preferred)
- Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and some experience with ICH
- Exposure to root cause analysis (RCA) and technical writing for quality investigations
- Experience reviewing and executing Manufacturing Batch Records and Good Documentation Practices
- Ability to perform AQL visual inspections and in-process audits on the manufacturing floor
- Knowledge and use of risk management tools (FMEA, HACCP, PHA) and familiarity with ICH Q9
- Exposure to lean operational excellence
- ASQ certification
- Ability to participate in CAPA issuance, deviation review, and root cause methodologies (5 Whys, fishbone)
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
