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Pharmacology QA Specialist

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Cameron Craig Group

2021-12-03 07:45:53

Job location Ridgewood, New Jersey, United States

Job type: fulltime

Job industry: Healthcare & Medical

Job description

My client is expanding and seeks a QA Specialist to support regulatory efforts. The ideal candidate will take on the following tasks:

* Conducts inspections of facilities, vivarium, and laboratories, evaluating current practices and procedures.
* Performs audits of study plans, study raw data, and final report audits for accuracy and completeness, verifying that the final report accurately reflects the raw data generated.
* Offers recommendations to vivarium and laboratory procedures to facilitate compliance with IACUC protocols, program methods and SOPs.
* Conducts in-life QC inspections of study test procedures for compliance and conformance to the approved IACUC protocol, the final study plan, and SOPs.
* Conducts post-approval monitoring of rodent behavioral and technical procedures in alignment with approved IACUC protocols.
* Ensures knowledge of EPA, FDA, GLP regulations, and any other related state and federal regulations.

The ideal candidate will possess the following:

* BS/MS degree and 5+ years experience including some rodent behavioral experience.
* Knowledge of EPA, FDA, GLP regulations, state and federal regulations, and commonly used concepts, practices, and procedures within the QA field.
* Ability to multitask and work under pressure of multiple projects and deadlines.
* Good problem-solving, analytical skills and excellent interpersonal skills.
* Must be able to record and keep essential records for a regulated environment.

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