Quality Assurance Specialist job in Bloomington, USA

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Last Name*

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Phone Number*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Bloomington, IN.

Job Responsibilities:

Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the manufacturing sites and associated off-site storage locations.
Support site qualification activities and development of quality agreements in accordance with company standards.
Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure company products/processes comply with cGMP requirements.
Support regulatory submission activities, and lead inspection readiness activities in partnership with external manufacturing site and our client to support global health authority approvals.
Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CAPA management, escalation of critical issues, and change control.
Monitor external manufacturing quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.
Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.
Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc.) to meet patient supply requirements
Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
Ability to work from home 20% depending on activity needs

Skills and Requirements:

Bachelor's Degree with a concentration in science, or an equivalent technical discipline
Minimum of 5 years working in an FDA regulated environment
Experience in pharmaceutical aseptic manufacturing operations and quality assurance
Detailed knowledge of cGMPs related to pharmaceutical production
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and make critical decisions with limited information required
Validation quality assurance experience is required

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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