Supervisor, Quality Assurance (2nd Shift)

6/7/21

Burlington, MA 01803

1261

FullTimeRegular

Supervisor, Quality Assurance (2nd Shift)

Supervisor, Quality Assurance provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Assurance Supervisor will be knowledgeable of industry regulations, industry best practices, and phase appropriate quality systems. This person must be quality focused and understand aseptic processing and the associated quality systems. This person is responsible for oversight of quality operations activities. In this capacity, the incumbent can perform the final disposition of executed batch records, approve quality departures (i.e. unplanned deviations, CAPA's, planned deviations), and approve procedures. Additional responsibilities may include representing Quality Assurance in operations meetings, project meetings, client meetings, and inspections. The Quality Assurance Supervisor must be highly organized demonstrating excellent communication skills and may organize/delegate workload among Quality Assurance. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities:

  • Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on
    Quality Assurance (QA) activities such as the following:
    • Executed/Unexecuted Batch Record Review.

  • Oversee and implement On-floor QA Executed/Unexecuted Validation/Facility Protocols/Reports.

  • Investigation review/writing including Unplanned Deviations, Planned Deviations, Environmental Monitoring Excursions and Equipment Excursions.

  • Review of incoming materials/components.

  • SOP writing, review and revision.

  • Reviewing Change Controls.

  • Reviewing Facility Work Orders prior to filing.
  • The QA Supervisor works in coordination with the QA Management and Operations to ensure disposition timelines are attained

  • The QA Supervisor works in coordination with QA management to maintain Quality KPI’s

  • The QA Supervisor works in coordination with the QA Management to ensure client timelines are on schedule and attainable

  • Work in coordination with QA Management to ensure QA staffs are appropriately trained and procedures are being followed

  • Perform QA visual inspection activities associated with clinical and commercial drug product

  • Assist in assuming responsibility for the compilation of documentation, systems and controls, to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations

  • Participate in client calls

  • Participate in regulatory and client audits

Responsible for training and mentoring team members

Requirements
• Bachelor’s Degree in life science field; alternate fields of study may be considered in combination with significant Aseptic/Microbiological industry experience
• 5-8 years’ experience of pharmaceutical/biotechnology or medical device industry experience; Minimum of 5 years’ experience in Quality Assurance
• Excellent written and verbal presentation and communication skills
• Former supervisory experience preferred
• Strong problem solving skills, with the ability to resolve conflict
• Previously experience in the review of validation (process, IOPQ) protocols and reports preferred
• Knowledgeable in FDA, cGMPs (21 CFR, 210/211, 820, and 600); ISO 9001 and 13485 a plus
• Ability to effectively present information to management and/or peers
• Comfortable working independently in combination with individuals in other departments across the organization
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