Quality Assurance Specialist
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Summary
The Quality Assurance Specialist ensures laboratory compliance with GMP/GLP standards by performing investigations, internal audits, and protocol reviews. The role involves collaborating with teams to maintain quality metrics and supporting client audits within a biopharmaceutical laboratory environment.
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Applies the highest quality standard in all areas of responsibility
- Demonstrates and promotes the company vision · Regular attendance and punctuality
- Applies the highest quality standard in all areas of responsibility
- Demonstrates strong client service skills, teamwork, and collaboration
- Proactively plans and multitasks to maximize productivity
- Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
- Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories
- Demonstrate understanding of QAU operations and functions
- Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents
- Perform investigation writing and review including thorough root cause analysis and CAPA review · Perform internal audits and walk through inspections
- Review procedures, methods and protocols · Release analytical reports
- Assist in hosting client audits
- Provide information/entries for monthly/quarterly quality reports to management
- Conducts all activities in a safe and efficient manner
- Communicates effectively with clients and staff members
- Performs other duties as assigned
- Investigation review
- Stability QA for protocols
The ideal candidate would be/have:
- Motivated to be accurate and produce high quality work, with minimal supervision
- Planning, organization, and work management (multi-tasking) and follow-up skills
- Work at maximum efficiency; quality orientation; high attention to detail; meticulous work habits;
- Communicate effectively, both orally and in writing; good judgement, decision making, and problem solving; initiative and innovation abilities;
- Good computer, office equipment, and typing skills;
- Accept changes in schedules and versatility of workload and a willingness to adjust to corporate needs; work overtime if necessary;
- Professional in appearance, conduct, and company representation;
- Logical thinking process; follow and give detailed verbal and written instructions; clear understanding of priorities
Basic Minimum Qualifications:
- Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration and some laboratory experience;
- At least two years related industry experience including some Quality Assurance responsibilities
Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Portage, MI are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.