QC Manager, Bioassay/Virology
Fujifilm
- Holly Springs, NC
- Permanent
- Full-time
- Ensures GMP compliant laboratory operations according to GMP guidelines
- Manages the daily activities of the QC Bioassay & Virology together with the planners in the team, and assuring dedicated focus on release, stability and clinical testing, including prioritizing work
- Ensures overall performance of QC Bioassay & Virology according to KPIs - assuring turn-around-times of all release, stability and clinical testing performed in the QC Bioassay & Virology department
- Assures timely analysis, review and approval of results in support of on time CoA issuance or stability time point
- Oversees and manage laboratory exceptions and investigations and assure timely closure within the group according to Quality metrics
- Motivates the group to perform as efficient as possible to reduce turn-around-times for release of commercial, stability and clinical products.
- Manages and prioritizes the preparation of procedures, protocols and associated reports for various deliveries.
- Leads projects, like method transfers and method qualifications in support of new product introduction for new and existing customers.
- Prioritize and focus on optimized laboratory systems, including the use of IT systems, e.g. Labware, identify and implement needed procedural and/or policy changes in areas where needed. Enforce established policies, processes and procedures and identifies areas where enhancements will improve
- daily work
- Leads a team responsible for executing analytical methods that require aseptic techniques including: viral infectivity assays, qPCR assays, cell-based assays, and clean cell culture
- Manages, directs and monitors lab activities and team as needed
- Leads method verification, qualification, and validation activities and maintain lab equipment
- Authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations and investigations for the QC
- Bioassay/Virology team as needed
- Ensures department is ready for customer visits, audits and regulatory inspections
- Performs investigations, manages complex issues, barriers, and problems to support team success
- Approves data reports within the team and area of discipline/focus, including approval of results
- Supports management for activities related to compliance with policies
- Provides leadership and mentoring as needed to aide in the development of the team
- Provides technical leadership through effective project management, status tracking including analytical improvement projects and technical problem solving with independence
- Proactively identifies technical gaps and areas for improvement related to quality
- Represents QC Bioassay/Virology on cross-functional Tech Transfer teams in support of implementing, transferring, and/or validating client methods ahead of new program campaigns
- Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management
- Performs other duties, as assigned
- Bachelor’s degree with 8+ years of experience in a GMP environment OR Master’s Degree with 6+ years of experience in GMP environment OR Ph.D. with 4+ years of experience in GMP environment
- Previous QC Bioassay and Virology leadership experience
- Advanced knowledge in Bioassay and Virology testing methods
- Previous QC Bioassay and Virology leadership experience in a GMP environment
- Ability to stand for prolonged periods of time up to 120 minutes
- Ability to sit for prolonged periods of time up to 240 minutes
- Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
- Ability to conduct work that includes moving objects up to 33 pounds
- Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height and use twisting motions.
- Ability to work in environments between -20 and -70 C for a few minutes with appropriate PPE
- Will work in heights greater than 4 feet