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Company

Original Job Post

Katalyst HealthCares & Life Sciences · 2 days ago

Quality Assurance Sr. Specialist

Boston, MA

Full-time

Onsite

Senior Level

5+ years exp

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H1B Sponsorship

Comp. & Benefits

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Responsibilities

Provide on-the-floor Quality support to manufacturing, review documentation, and make quality decisions and/or escalate issues to management that may impact operations.

Participate in quality oversight of manufacturing through real-time observations of activities.

Participate in quality focused teams across Moderna's broad ecosystem of functions.

Authors and reviews SOPs, policies, and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.

Oversee and review batch record documentation.

Review/Approve manufacturing deviations, change controls and CAPAs.

Closely partner with peers for disposition of Small Molecules.

Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.

Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.

Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.

Monitor process operations to ensure compliance with specifications.

Utilize knowledge to improve operational efficiency.

Qualification

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GMP ManufacturingClinical Quality Assurance

Required

A minimum of 5 years' experience in a GMP manufacturing environment

Bachelor's degree in biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field

Seven years of experience in a clinical quality assurance environment

Company

Katalyst HealthCares & Life Sciences

Katalyst Healthcares & Life Sciences offers data management, analysis, quality assurance, pharmacovigilance, and human resource services.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

H1B Sponsorship

Katalyst HealthCares & Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (20)

2022 (46)

2021 (43)

2020 (53)