Job Description

Eurofins Lancaster Laboratories PSS is searching for a Quality Assurance Laboratory Specialist in West Point, PA.

The Quality Assurance Laboratory Specialist ensures that all necessary laboratory documentation (CRs / ACRs, IOQs, PQs, etc) is reviewed, approved, valid and compliant with all site procedures, following Policies and Guidelines and Regulatory requirements.

This person is responsible for working closely with the various groups within Laboratory Operations in a team environment to enable the timely testing and subsequent release of product to the marketplace.

The Quality Assurance Laboratory Specialist is responsible for providing Quality direction and oversight to WP Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Documentation, Deviation Management and Risk Management in order to maintain compliance with Regulatory requirements.

The individual is an Advocate for the development, execution, and deployment of WP Site and priorities. He or she will assist in driving quality improvement activities and will work to ensure alignment across Laboratory Operations.

The Quality Assurance Laboratory Specialist will also train to provide support to Quality Assurance system functions and support Regulatory Agency inspections.

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.
• 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.

Qualifications

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

Additional Information

Position is full-time and permanent, Monday-Friday, 8am-5pm with over time as needed. Candidates currently living in a commutable distance to West Point , PA are encouraged to apply.

On-site work is expected in order to be effective in this role.

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 Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com .

Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Last updated : 2024-05-17