QA Deviation Specialist – Pharma

Job Title: QA Deviation Specialist Pharma

Location: Round Lake, IL

Employment Type: Contract (6 Months)

Job Responsibilities:

• Lead Minor, Major, and Critical deviation investigations.
• Review manufacturing records, data, and documents to identify issues.
• Perform Root Cause Analysis (RCA) to find the cause of deviations and assess product impact.
• Develop and track CAPAs to prevent issues from happening again.
• Analyze deviation trends and identify recurring quality issues.
• Prepare and complete accurate investigation reports on time.
• Follow up on CAPAs to ensure they are implemented effectively.
• Communicate project updates and progress reports to clients and management.
• Ensure timely approval and closure of deviation reports.
• Support FDA remediation activities and ensure compliance with GMP and quality standards.

Required Qualifications:

• Bachelor's degree in a relevant field.
• 10+ years of experience in aseptic processing or pharmaceutical manufacturing.
• Strong experience handling manufacturing deviations and writing investigation reports.
• Good knowledge of deviation management, Root Cause Analysis (RCA), and CAPA.
• Experience supporting FDA audits, observations, and remediation activities.
• Extensive Quality Assurance experience in pharmaceutical manufacturing.
• Strong understanding of GMP, pharmaceutical quality systems, and regulatory requirements.

Preferred Qualifications:

• Experience in key QA activities, including PQR, audits, change control, complaints, OOS investigations, batch record review, and documentation.
• Knowledge of training programs, supplier quality, and pharmaceutical quality systems.
• Understanding of GMP and regulatory compliance requirements.
• Strong communication, teamwork, and problem-solving skills.
• Experience tracking quality KPIs, project progress, and investigation timelines.
• Ability to handle multiple investigations and work with cross-functional teams in a fast-paced pharmaceutical environment.

Pay Scale Anticipated hourly pay rate: specific range such as ($60/hr to $65/hr) - DOE.

Benefits Employees hired into this position may be eligible for benefits, subject to applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options may be available through a third-party provider. Employees may be responsible for some or all of their insurance premiums, depending on the applicable plan.
• Retirement Benefits: A 401(k) retirement savings plan may be available, subject to plan eligibility and applicable terms.
• Paid Time Off (PTO): PTO eligibility is subject to the applicable employment agreement and state and local requirements.