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.