Person, Text, Face

Supervisor, Quality Assurance (QA) 2nd Shift

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Supervisor, QA Batch Review drives the review of batch records, processes and daily tasks, and provides direct supervision for personnel performing QA review of batch records. This role is responsible for ensuring that GxP compliance is maintained in batch production records. Additionally, this role is responsible for training and scheduling of staff to support routine operations (evenings, weekends and holidays) as well as QC routine release of raw materials, in-process materials and reagent kits.

This role will work the Wednesday-Sunday 3pm-11:30pm shift.

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Key Responsibilities

• Deliver training for personnel in the Quality Assurance review and approval of Batch Records.

• Publish schedule for routine coverage and gaps as applicable (including holidays evenings and weekends).

• Manage logs and generate metrics to report status updates to management (daily, monthly, quarterly).

• Communicate delays and escalate concerns raised to management.

• Become a SME and ensure GxP compliance support for the batch review process.

• Write, collaborate and, review, SOPs, tracking forms, logs related to QA processes for Batch review (inputs and outputs).

• Revise QA procedures to include any changes to laboratory processes as applicable.

• Be included in the rotation for routine weekday, weekend, evenings and holiday schedule.

• Other duties as assigned.


Basic Qualifications

• Bachelor's Degree in Science and 4+ years of QA experience; OR,

• High School Diploma/General Education Degree and 6+ years of Quality Assurance Operations experience

• Experience working in an FDA regulated, GxP environment and familiarity with 21 CFR Part 11

Preferred Qualifications

• Experience providing guidance for FDA GMP, GCP, and 21 CFR Part 11 compliance

• Knowledge of GxP regulations including but not limited to FDA, CLIA, GCP, CAP, MA state, NY state and HIPAA (importance of privacy of patient data)

• Advanced knowledge of Microsoft office and familiarity of database platforms (e.g. LIMS)

• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, mentoring and problem solving with departments and colleagues

• Excellent attention to detail and multitasking skills

• Detail oriented with excellent prioritization and organizational skills in a fast-paced environment

• Commitment to FMI values: patients, innovation, collaboration, and passion


Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Scientist I, Research & Early Development

Research and Early Development 100775 San Diego California United States Towne Centre Ct., San Diego, California, United States R&D
About the Job The Scientist I role is part of the Research and Early Development team in FMI’s Product Development group. This position explores new technologies and biomarker candidates to address unmet needs in the oncology field. The position ...

Competitive Intelligence Intern (Graduate)

Strategic Insights, Analytics and Enablement 100619 United States United States Global Portfolio Strategy
About the Job The Intern, Competitive Intelligence supports the Strategic Insights & Analytics team. The team is responsible for providing competitive and strategic insights across FMI (Commercial, Biopharma, Data, Medical, R&D and Operat...

Senior Scientist, Companion Diagnostics

Development Operations 100710 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States R&D
About the Job The Senior Scientist, Companion Diagnostics sits on the Companion Diagnostics (CDx) Development Operations Team and is responsible for developing companion diagnostics and for contributing to the regulatory strategy of new NGS-based...

Senior Director, Global Supply Chain & Materials Manufacturing

Facilities 100641 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Operations
About the Job The Senior Director, Global Supply Chain & Materials Manufacturing leads a team of 20+ employees across the United States with a matrix in FMI’s International site to ensure best in class operational performance end to end. This...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Person, Clothing, Shoe, Crowd, Sitting, People, Wood, Pants, Face, Coat

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.