Quality Assurance Specialist Job

QUALITY ASSURANCE SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in LOUISVILLE, KY.

WHAT YOU'LL BE DOING:

- Immediately triage quality issues as they occur and facilitate the communication flow between the contractor and the various Vaccine & Drug manufacturing sites and Global Quality Operations.
- Provide local disposition of vaccine products at distributor location in coordination with various company site quality organizations.
- Manage review and approval of transportation data.
- Manage product returns, withdrawal and recalls.
- Ensure that the third party distributors perform their services within the scope of the Quality Agreement.
- Participate in distributor compliance audits.
- Participate in the quality risk assessment of distributors and the ongoing monitoring process.
- To work in collaboration with the third party distributor and various Vaccine & Drug Quality groups to approve Vaccine & Drug product specific work instructions and SOPs.
- To work with third party Quality functions to ensure appropriate Vaccine & Drug specific training modules are developed and training is performed.
- Participate in investigations pertaining to distribution excursions and/or deviations in collaboration with the company quality units.
- Responsible for tracking of CAPA/remediation plans eg risk mitigation plan or CAPA due to deviation and ensure the progresses on the actions defined and collaborate with Global GMP Compliance in order to ensure the progress of audit CAPAs.
- Provide support of cold chain transportation validation.

WHAT YOU NEED TO BRING TO THE TABLE:

- Experience with quality assurance in a pharmaceutical environment
- Experience with developing training modules
- Global GMP compliance experience
- Experience with tracking of CAPA/remediation plans eg risk mitigation plan or CAPA due to deviation and ensure the progresses on the actions defined and collaborate with Global GMP
- Must have experience with risk management and quality audits
- Some domestic and international travel required

WHAT'S IN IT FOR YOU?

- This is a wonderful opportunity for you to play an integral role at a growing site within one of the largest and most respected pharmaceutical companies in the world.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kathy Pavlick

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

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