Quality Assurance Laboratory Specialist

Posted on Sep 21, 2024 by Eurofins USA PSS Insourcing Solutions
West Point, PA
Research
Immediate Start
Annual Salary
Full-Time
Job Description

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.

Reference: 202109399

https://jobs.careeraddict.com/post/95491446

Quality Assurance Laboratory Specialist

Posted on Sep 21, 2024 by Eurofins USA PSS Insourcing Solutions

West Point, PA
Research
Immediate Start
Annual Salary
Full-Time
Job Description

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.

Reference: 202109399

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