Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

Even if you don’t see a job that’s a fit, but you’re excited by what Seres is doing and want to be a part of it, we’d appreciate hearing from you and will keep you in mind for a future opportunity. Click here to submit your resume. 


Principal Associate, Quality Assurance - Contract

Department: QA
Location: Cambridge, MA

*Contract opportunities are manged directly by Stratacuity.

Principal Associate, Quality Assurance

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases, and are designing live bacterial ecologies to act as therapeutics.

What’s Your Mission?

The Principal Associate, Quality Assurance will work closely with Donation Operations to develop and execute goals and objectives. This is a highly visible and business critical position; the impact you have on Seres as a key contributor is tremendous. This is a fabulous opportunity for an experienced professional to gain oversight of our Donation Collection Facilities and internal operations, including assisting with the monitoring of Quality Management Systems.

What You’ll Do

  • Provides quality guidance and support for Donation Collection Facilities and Donation Operation's projects and programs, ensuring compliance with regulations and internal policies.
  • Perform detailed record reviews to support the Certificate of Conformance for Starting Raw Material.
  • Assists with the Quality Process Review (QPR) Program. Participates in QPRs of donation collection sites, testing laboratories and donation operations activities to identify areas for improvement as well as best practices. Prepares QPR plans, checklists and summary reports. Works with QA Donation Operations Management to ensure follow up activities are completed.
  • Assists with investigations, corrective actions and tracking of Donation Operations and collection site deviations and CAPAs.
  • Manages documentation transition to archive, including but not limited to deviations, CAPAs, change control documents and logbooks.
  • Performs log book review for receipt and tracking of Starting Raw Material and associated retains.
  • Assists Donation Operations with SOP development embedding appropriate GMP requirements.
  • Assists with compilation of quality metrics.
  • Other duties as assigned including provide support to other quality groups as needed.
  • Occasional Travel required to sites for audits and record gathering.

What You’ll Bring

  • Bachelor of Science degree or equivalent in life sciences or engineering.
  • Minimum 8+ years of well-rounded Quality experience in the pharmaceutical or biotechnology industry including GMP internal auditing.
  • Experience in the preparation, conduct, reporting of audits and the translation of findings into effective corrective actions plans that mitigate risks to the company.
  • Experience in Batch Record Review, deviation/CAPA investigation, audit performance and reporting, and problem solving.
  • Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and customer management skills.
  • ASQ Certified Quality Auditor (CQA) preferred.

 

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. For more information, please visit http://serestherapeutics.com/

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