Quality Assurance Laboratory Specialist

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.
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.