Senior Quality Assurance Specialist
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.
With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
The Senior Quality Assurance Specialist will be responsible for conducting routine GMP QA operations in support of Finch’s internal manufacturing of complete consortia product pipeline. Responsibilities include, but are not limited to, review quality documents and executed batch records, conduct deviation investigation, resolve quality issues, conduct material release, review analytical raw data, represent QA Ops in project teams, etc. This role will also assist in conducting risk assessment, mitigation and support all Quality related activities, such as Change Controls, CAPAs, Deviations, and Complaints.
The Senior Quality Assurance Specialist will be a champion for quality principles and practices, risk management, and compliance for the organization.
- Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing)
- Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
- Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations
- Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments
- Independently handles complex investigations in cross-functional areas; anticipate issues and escalate to appropriate management attention as necessary
- Exercises judgment in resolving moderate to complex quality issues
- Provide quality assurance expertise to help identify solutions and ensure compliance to cGMP requirements; execute work independently and consult with supervisor as needed
- Provide QA review and disposition of incoming raw materials and consumables and provide oversight for product shipments
- Support QA on the floor activities as required
- Review analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
- Support process transfer from early and late stage process development for clinical and commercial manufacturing
- Provide guidance to junior team members as needed
- Participate and serve as QA Ops representative project teams
- Perform other duties as applicable
- Bachelor’s degree in biology, chemistry, or other life science and at least 8 years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment
- Expertise working within cGMP compliance and providing GMP documentation
- Deep and broad understanding of quality processes including change control, process control, risk assessment and management, and root cause analysis
- Experience developing and executing tech transfer into cGMP commercial manufacturing facility
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
- Excellent verbal and written communication skills
- Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized
- Strong problem solving, trouble shooting, and analytical skills
- Ability to constructively progress to outcomes despite uncertainty or ambiguity
- Ability and desire to work in a fast-paced and dynamic environment
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Only facility-dependent employees are working on-site in Somerville until further notice.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.