QA Specialist I - OPS

pciservices; Madison (WI); On-site; USD 75,000 - 105,000; Full time

Job summary

PCI Pharma Services in Madison, WI seeks a QA Operations professional to review batch documentation for release, oversee CAPA programs and ensure GMP compliance. The role requires 3–5 years in pharma/biotech QA and familiarity with FDA 21 CFR Part 820.

You will collaborate across QA, manufacturing and technical transfer to maintain quality and drive improvements. The ideal candidate will have strong problem-solving, technical writing skills, and the ability to guide complex investigations while

Qualifications

• Bachelor's Degree in a relevant scientific field preferred.
• 3-5 years of pharmaceutical or biotech industry experience.
• 2+ years in a QA Operations role supporting late stage clinical and/or commercial production.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ.
• Exposure to RCA, technical writing, and quality investigations.
• Equivalent combination of experience and education may be considered.
• Exposure to lean operation excellence desirable.
• Knowledge of FDA regulations (21 CFR Part 820).
• Ability to apply scientific principles to operational tasks.

Responsibilities

• Review batch documentation for release of internal and external clinical or commercial products per cGMPs and regulatory requirements.
• Prioritize record review to support business needs and communicate release needs across the organization.
• Review and approve master batch records to initiate GxP manufacturing activities.
• Oversee deviations, investigations and CAPA programs.
• Review investigations in support of batch release and GMP compliance.
• Provide direction for complex investigations and CAPAs.
• Ensure timely execution and documentation of quality events.
• Develop and improve quality system procedures and test methods.
• Review and approve CAPAs and Change Controls.
• Track investigations and change control and provide status reports.
• Collaborate with internal and external customers on quality/compliance matters.
• Lead quality process improvements and communicate status to management.
• Serve as QA representative to cross-functional teams (tech transfer, process validation, improvement).

Skills

GxP Compliance

Documentation Review

Quality Systems

Regulatory Knowledge

CAPA Handling

Education

Bachelor's Degree

Tools

IQ/OQ/PQ Procedures

MS Office

Job description

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
• Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
• Review and approve master batch records for the timely initiation of GxP manufacturing activities.
• Responsible for quality oversight and administration of the deviation/investigation and CAPA programs.
• Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance.
• Provide direction for complex investigations and CAPAs.
• Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs.
• Review, develop, and improve quality system procedures, specifications, and test methods.
• Review and approve CAPAs to prevent recurrence of deviations.
• Review and approve Change Control documentation.
• Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process.
• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
• Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management.
• Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement.

QUALIFICATIONS

Required

• Bachelor's Degree in a relevant scientific field is preferred.
• 3-5 years of pharmaceutical or biotech industry experience.
• 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ.
• Exposure to RCA, technical writing, and working with quality related investigations.
• An equivalent combination of experience and education may be considered.
• Exposure to lean operation excellence highly desirable.
• Knowledge of FDA regulations (i.e., 21CFR Part 820).
• 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, PHA, etc.).
• Scientific, technical, and mechanical subject matter comprehension and aptitude.
• Able to articulate scientific and technical subject matter.

Preferred

• ASQ certification is referred.
• Strong organizational skills and attention to detail.
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing.
• Proficiency in MS Office including Word, and Excel.
• Ability to work in a dynamic, fast-paced work environment.
• Honesty, integrity, respect and courtesy with all colleagues.
• Able to work with some limited supervision, able to elevate issues as needed.
• Is flexible and adaptable through operational and organizational change.

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