QA Deviation Approver

Title : QA Deviation Approver

Location: Madison, WI (100% Onsite)

Employment Type: Contract

Duration: 6 Months+

Hours: 40+ hours per week (occasional overtime)

Job Responsibilities

• Review and approve cGMP deviation records and investigations to ensure they are complete, scientifically sound, timely, and compliant with regulatory requirements and site procedures.
• Assess event classification, investigation scope, root cause, product and process impact, batch disposition implications, and escalation requirements.
• Evaluate CAPAs, effectiveness checks, and recurrence-prevention actions to ensure they address verified root causes.
• Apply quality risk-management principles to assess impacts on materials, equipment, processes, batches, and products.
• Partner with Manufacturing, QC, Engineering, and Process Development teams to investigate process events, excursions, alarms, and atypical data.
• Identify recurring events, quality trends, documentation gaps, and improvement opportunities.
• Review related CAPAs, change controls, impact assessments, and controlled GMP documentation.

Required Qualifications

• Relevant QA experience reviewing and approving cGMP deviations and investigations in pharmaceutical or biotechnology manufacturing.
• Direct experience in both biologics manufacturing and drug substance/API manufacturing.
• Working knowledge of cGMP, deviation management, CAPA, change control, batch documentation, and quality risk management.
• Ability to evaluate manufacturing records, process data, laboratory results, and supporting evidence to determine product, process, and batch impact.
• Experience with biologics processes such as cell culture, downstream purification, chromatography, TFF, buffer preparation, single-use systems, or fill/finish.
• Strong root-cause analysis and CAPA review skills, including the ability to identify investigation gaps and make evidence-based quality decisions.
• Strong technical writing, communication, and organizational skills.
• Ability to manage multiple investigations and timelines.

Preferred Qualifications

• Experience supporting clinical, late-phase, PPQ, or commercial manufacturing programs.
• Familiarity with electronic quality or manufacturing systems.
• Associate degree with 6 8 years of relevant experience, bachelor's degree with 3 4 years, or master's degree with 1 2 years of relevant experience. Equivalent combinations may be considered.

Pay Scale

• Anticipated hourly pay range: $35/hr to $42/hr on W2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.