Qa Associate I - Ops

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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.