QA SupervisorReports To:
Director of QAGroup/Division:
Franklin, MADirect Reports:
This position is responsible for all QA/QC activities for the site in which they are located. Must be fully aware of all Quality systems as they relate to Fisher BioServices at the Franklin MA, facility. This includes but is not limited to logging all events in real time, track and trend event data, and maintain and initiate proper documentation for all quality events. Reviewing and approving site specific documentation and/or validations. Ensuring quality system adherence with the Franklin, MA. Key contributor to QA group on procedures and policies.Key Responsibilities:
- Monitor and maintain the Quality systems in compliance with the corporate QA processes and policies.
- Responsible for implementation and execution of the QA Plan for the site.
- Trend and post QA metrics to detect any recurring quality issues at site located.
- Provide GxP training to site located and others.
- Host/Lead Client audits at the site, provide audit response and verify corrective actions.
- Assist and verify QC in place and employees following process at site located.
- Work with all departments on daily basis to build quality and focus.
- Review QA/QC paperwork, validations, and calibrations as necessary.
- Performs other duties as assigned by his/her supervisor.
- BS/BA degree or equivalent in scientific or compliance related field
- Experience in an FDA regulated environment.
- Experience with, and implementation of cGMP's, calibration, and validation.
- Knowledge of general repository operations; shipping, receiving, cold temp. storage.
- Good understanding of cGMP quality standards.
- Ability to handle multiple tasks while ensuring timely and accurate completion.
- Self-starter with the ability to work with a minimum of supervision.
• Three to five year minimum experience working in quality role in GMP environment.
• Ability to work independently and as part of a team.
• Proficient in cGMP requirements as they relate to the repository
• Proficiency in application of 21 CFR Parts 11, 210, 211, and 820
• Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
• Excellent written and oral communication skills.
• Extremely adept in attention to detail/follow up.
• Excellent interpersonal skills, problem solving skills, planning/organization skills, and customer focus.Working Conditions
:Environment (Office, warehouse, etc.) -
Office and warehouse, Exposure to dry ice, liquid nitrogen cryogenics, hazardous, and infectious agents including need to work in a -20 degree C walk-in freezer for periods of time.Physical Requirements (Lifting, standing, etc.) -
Must be able to stand for up to 8 hours per day. Ability to lift up to 50 lbsNon-Negotiable Hiring Criteria:
- Strong attention to detail
- Problem solving skills
- Ability to work independently