#OurCodeCrushesCancer
Curious how you can help? Good. Curiosity is our most important requirement.
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.
Qualifications
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
Internal applicants, please use your FMI email address.
Thank you
Thank you for sending this job to your friend.
Our recent Hackathon brought our colleagues from all departments and regions together to create & innovate.
This website uses cookies.
We use cookies to personalise content such as job recommendations, and to analyse our traffic. You consent to our cookies if you click "I Accept". If you click on "I Do Not Accept", then we will not use cookies but you may have a deteriorated user experience. You can change your settings by clicking on the Settings link on the top right of the device
Enter your details and we will notify you when new roles that might be a fit are posted!
Thank you