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.
• 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.
• 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
• 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.
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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)
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