Quality Assurance Laboratory Specialist responsibilities include, but are not limited to, the following:
- Responsible for Quality oversight for the Laboratory shop floor.
- Actively participates in the Tier process and use this forum to escalate concerns and best practices.
- Performs Quality review and approval of investigative events in Laboratory Operations.
- Determines the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product’s quality.
- Provide input on recommended CAPAs, as appropriate.
- Performs review and approval for CAPAs, QCTS commitments, change requests, investigative protocols and final reports.
- Performs review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility.
- Completes training to become a qualified auditor and performs monthly internal audits of laboratory areas.
- Writes, reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
- Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel.
- Provides support to Regulatory Agency inspections as needed.
The ideal candidate would possess:
- Progressive and demonstrated Quality decision making responsibility
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
- Demonstrated self-starter with capability to develop innovative solutions to challenges.
- Proven analytical aptitude, critical thinking skills and ability to apply key concepts.
- Speaks with courage and candor.
- Strong written and verbal communication skills.
- In-depth working knowledge and application of GMPs / GLPs.
- Proven ability to manage multiple projects simultaneously.
- Experience in pharmaceutical laboratory operations or related environment.
Basic Minimum Qualifications:
- Degree in Biology, Cell Biology or Virology is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
- Experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
- 8+ years in science industry experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday - Friday 8:00am - 5:00 pm with overtime as needed. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.
What we offer:
- 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
- Yearly goal-based bonus & eligibility for merit-based increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
