Principal Associate, QA Specialist, Greater Phoenix Area

Serestherapeutics (Maluku, Indonesia) 11 days ago
Quality Systems - QA
tbd, MA

Principal Associate, QA Specialist, Greater Phoenix Area

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.  Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. 

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Position Summary

Reporting to the Director, QA Donor Operations, the Principal Associate, Donor Operations Quality Assurance will work closely with our operational teams to support the collection of donor derived products. You will be involved in the quality support of collection facility personnel as well as engaged in the review of batch records to ensure the appropriate release of donor material to serve at risk populations. Please note this role is on-site.

What You’ll Do

This is an exciting opportunity for anyone who excels at active, and creative problem solving. While this is a GMP environment, it is not your typical experience, our program requiring a unique opportunity to apply GMP principles to an area as yet unregulated by the FDA. Our unique product provides the opportunity to grow within a cutting edge GMP program, setting the benchmark for a new industry.

This role requires not only a strong application of GMP principles, but curiosity and attention to details in a fast-paced environment. You will have the opportunity to be a key contributor to the program as well as grow with the organization as it brings a pioneering product to the market. Due to the unique nature of our product, this is not a cookie cutter assembly of requirements, and requires an excitement and attention to detail to understand the unique biology of our product, and the controls necessary to support it. If you’re excited about the opportunity to learn and apply quality controls to a new product, and to grow with our organization, this may be the right place for you.

Key Responsibilities

•Provides quality guidance, support and reviews for a Donation Collection Facility and Donation Operation's projects and programs, ensuring follow up activities are completed and in compliance with requirements.

•Perform detailed batch record reviews and participate in Donor Review Committees.

•Perform initiation, investigation, and corrective action monitoring for deviations and CAPAs related to donation collection facilities or other assigned Donor Program areas.

•Perform record retention and archival tasks, including but not limited to deviations, CAPAs, change control documents, batch records and logbooks.

•May participate in development, review and training of Donor Program processes/procedures.

•Other duties as assigned including providing support to other Seres quality groups as needed.

•Occasional travel may be required to Donation Collection Facilities.

What You’ll Bring

•8-12 years of quality experience, and a Science or Engineering degree.

•Experience in batch records or GMP auditing is required, as well as in investigation and corrective action assessment for deviations and CAPAs.

•Strong verbal and written communication are essential, as well as strong interpersonal skills as we work across department lines to ensure we can support donation activities, and the needs of Seres Therapeutics overall.

•ASQ Certified Quality Auditor (CQA), or equivalent, a plus.

Principal Associate, QA Specialist, Greater Phoenix Area

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