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