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QA Specialist I

Company: Seres Therapeutics
Location: Somerville
Posted on: January 10, 2022

Job Description:

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 of Quality Assurance, this role will be critical in supporting the growing needs of our manufacturing and analytical functions. Provides Quality Oversight for Manufacturing and Quality Operations, including documentation review of executed quality records.What You'll Do --- Partner with the members of QA, QC and Manufacturing in batch production activities providing quality guidance of quality issues.--- Responsible for escalation of quality deficiencies identified in the production process--- Attend and participate in all Quality Meetings.--- Performs reviews of internal and external batch documentation, records and reports.--- Review QC data generated as to the acceptance to established product specifications.--- Perform lot disposition activities for intermediate and final batches.--- Partner with members of QA, QC and Manufacturing in batch production activities providing subject matter expertise of general quality items--- Provide guidance and support with resolution of investigations and CAPA's.--- Assist in the authoring and review of SOPs and applicable policies.--- Other duties as assigned.What You'll Bring --- Bachelor of Science degree or equivalent experience in life sciences or engineering.--- Minimum 5 years of Quality experience in the pharmaceutical or biotechnology industry--- Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and customer management skills.--- Experience working in cross functional teams and managing the relationships and expectations of several key stakeholders.--- Experience working collaboratively with CMO's (Contract Manufacturing Organizations)Candidates should be aware that Seres Therapeutics currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date.Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

Keywords: Seres Therapeutics, Somerville , QA Specialist I, Other , Somerville, Massachusetts

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