QA Operations Supervisor - Day Shift (On-site in College Station, TX)

The Quality Assurance (QA) Operations Supervisor, will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

Reports to Senior Manager, Quality Assurance

Work Location College Station, TX

Primary Responsibilities:

• Supervise and provide direction to direct reports.
• Serve as TrackWise Administrator.
• Monitor and support site and global quality policies and procedures to ensure GMP compliance.
• Work with QA management to design and implement quality assurance training programs for staff development.
• Provide cGMP guidance to operations, QC and QA.
• Lead client audits and regulatory inspections.
• Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
• Develop, motivate and lead direct reports towards achieving organizational and individual goals.
• Conduct periodic staff meetings.
• Review and/or approve basic and technical documentation to include, but not limited to:

-Standard Operating Procedures

-Batch Production Records (completed and approval)

-Commissioning, qualification and validation protocols and reports

-Deviation Reports

-Corrective Action/Preventive Action Plans

-Technical data review and approval

-QC data review and approval

-Drug Substance/Product Reports

• Manage Internal Quality audit functions to include, but not limited to:

-Audit of lab notebooks

-Audit of equipment logbooks

-Review of vendor, supplier, contract laboratory audit questionnaires

-Lead vendor, supplier, contract laboratory

• Identify process and Quality System improvement opportunities.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Assist with compliance related functions.
• Work as a team member; be cooperative with all departments and staff to meet company objectives.
• All other duties as assigned.

Qualifications:

• Master’s degree in a science-related field with 3+ years of related experience; OR
• Bachelor’s degree in a science-related field with 5+ years of related experience.
• 2+ years of supervisory or lead experience.
• 2+ years of cGMP experience.
• Certified Quality Auditor preferred.
• Degree in Biology or Chemistry preferred.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Develop staff to maximize contributions to the team and the company.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.