QC Microbiology Manager job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
Responsible for Environmental monitoring and trending program for a Sterile filling operation. Management and organization of media fill program & smoke studies for Sterile filling operation. Presenting environmental monitoring trends to senior management. Responsible as Aseptic lead/expert for the manufacturing facility. Manage delivery of analytical microbiology services to support product/process validation and product release in a way that:|
• Ensures a safe workplace
• Complies with established standards and procedures (e.g., cGxP and SOPs)
• Encourages growth and contributions by team members
• Meets or exceeds business requirements, quality standards, and cost
• Optimizes and improves quality and production processes
Safety/Housekeeping - Provide a safe working environment that complies with applicable standards (HSE, GMP, etc.), and that associates are working safely.
• Implement programs that encourage adherence to company and department HSE standards and priorities.
• Ensure teams work according to established standards and SOPs; engage associates to adjust behaviors as needed.
• Ensure work areas are clean and safe, and audit-ready at all times.
• Continuously monitor work areas; identify, resolve, and report safety hazards.
• Ensure materials are handled and disposed of properly, per HSE standards.
Planning - Set direction for teams to know what is expected, and why.
• Determine and communicate priorities based on product and release schedules.
• Develop team goals (people, safety, quality, supply, cost, etc.) that align with Department's annual objectives.
• Ensure regular communication of Company and Department objectives to all team members.
• Monitor, analyze, and control variables (e.g., operating costs, labor utilization).
• Maintain awareness of state-of-the-art equipment and processes; recommend and implement changes, as applicable.
• Prepare analyses and provide input to Site Management for use in strategy setting.
• Ensure lab complies with company, regulatory and compendial standards
• Manage and control the laboratory budget to meet established objectives.
Technical - Manage microbiology lab services, and monitor results to ensure alignment with goals.
• Ensure Environmental monitoring and trending program for a Sterile filling operation meets with company and regulatory requirements. Development and reporting to site leadership environmental monitoring trending data on monthly basis. Responsible for critical evaluation of EM data, investigation of any identified trends and implementation of identified CAPA's.
• Management and organization of media fill program & smoke studies for Sterile filling operation.
• Responsible for site aseptic training program.
• Responsible for environmental monitoring excursion investigations, ensuring correct root cause and appropriate CAPA's are identified.
• Ensure timely delivery of microbiology laboratory services to support product release and product stability standards, including evaluation of: critical systems; utilities; semi-processed materials; finished goods; incoming chemicals; packaging components; and environmental testing.
• Oversee implementation of systems, policies and procedures to ensure that the laboratory complies with company, regulatory and compendial standards (e.g, cGxP, SOPs).
• Monitor service delivery, identify problems, and initiate appropriate corrective actions, including deployment of available resources. Analyze and recommend/implement improvements to provide better service.
• Manage significant projects (e.g., lab equipment upgrades; computerization).
• Critically review operations for ways to improve regulatory compliance, aseptic techniques, product quality and/or productivity.
• Track, evaluate and report on key quality indicators to determine the need for corrective and preventative actions. Implement corrective and preventative actions when required.
• Maintain laboratory systems, equipment and analytical methods in a validated state.
• Manage and coordinate analytical method transfer from Product Development and R&D to the manufacturing site
• Lead/support investigations into complaints related to products or processes.
• Review and approve/concur on documentation pertaining to Quality and Manufacturing Systems and processes.
• Serve as a technical consultant to the manufacturing community.
Team - Support Supervisors to create a positive work environment that engages associates and enables strong performance.
• Hire, train, coach, and evaluate associates.
• Manage HR activities such as performance appraisals, training, interviewing, counseling, and staff and resource utilization.
• Develop organizational capability to identify and resolve technical issues quickly and effectively.
• Ensure supervisors staff their teams with capable associates who support company values and objectives.
• Ensure supervisors carry out activities to develop the KSAs (knowledge, skills, and abilities) of all associates.
• Ensure associates at all levels receive regular encouragement and feedback, both formal and informal. Celebrate successes.
• Identify top talent on each team, and ensure development plans for these associates are defined and implemented.
• Monitor the work environment to identify issues that affect teams, and implement action plans to address or correct.
• Ensure fair and consistent treatment of all associates, in accordance with company policies & procedures, as well as employment law.
• Lead by example, encouraging all associates to act in accordance with company values and behaviors.
Interfaces - Coordinate with other departments/organizations to accomplish objectives
• Support Quality Assurance, Production, and Materials Control to ensure operating targets are met.
• Provide technical expertise and testing support for other QA sections, including: Surgical, Process Development, R&D, International QA
• Support site during internal and external regulatory assessment activities.Minimum:
Bachelor's Degree or equivalent years of directly related experience
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience
5 Years of Demonstrated Leadership
M.S. in Biology or Microbiology, with 10+ years' experience in a multi-functional (microbiology) pharmaceutical laboratory environment, and 5+ years in a supervisory role