Supervisor QC Microbiology
Thousand Oaks, CA Posted: 9/14/2021
Our client, a global biopharmaceutical organization, is seeking to hire an experienced Quality Control Microbiology Supervisor at their fantastic facility in the Greater Los Angeles area. In this role you will plan, organize, supervise, and monitor the daily operations, activities, and workflow for the laboratory personnel in the Quality Control (QC) lab. You will also implement testing standards and policies, ensure safety measures are followed, assist laboratory personnel with career development and performance, and assist laboratory personnel in other areas as needed. Other duties and responsibilities include:
- Provide general oversight, plan, organize, direct and evaluate day to day laboratory tasks.
- Schedule, staff, train and audit various activities for area of responsibility.
- Ensure timely completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation.
- Assist with the implementation and interpretation of applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.
- Develop and manage the performance and talent of direct reports. Lead teams to resolve lab issues as needed.
- Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
- Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and combination drug manufacturing labs.
- Assist in plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations.
- Lead technical reviews, investigations, and process improvement projects.
- Identify, implement, and oversee changes within quality systems.
- Assure equipment maintenance and calibration, and internal audits are performed on schedule.
- Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.
- Serve as a backup for QC Manager in handling Quality and Regulatory Inspections.
- In-depth Knowledge of basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures
- In-depth knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
- Knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
- In-depth knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
- In-depth knowledge of quality systems including exception management, change control, document control, etc.
- In-depth knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory
- Requirements pertinent to pharmaceutical and medical device manufacturing labs a plus.
- Ability to write detailed investigation summary memos that consistently meet the requirements of the Quality Organization and the expectations of regulatory agencies.
- Understand how to implement investigation strategies and apply root cause failure analysis.
- Must be a solid team player, able to meet deadlines and changing priorities.
- Must be able to communicate effectively with managers, peers, and subordinates.
- Must be very detailed oriented and able to produce high quality of work.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have the ability to complete tasks with minimal direction from manager and/or supervisor.
- Must have the ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines.
- Laboratory management experience desirable/required.
- Must have decision-making skills, technical problem-solving ability, and analytical skills.
- Must have strong leadership, organizational and time management skills.
- Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
- Must be proficient in a variety of mathematical disciplines and be able to use and apply statistical tools.
- Proficiency with the MS Office suite of programs (including Microsoft Word, Excel, and PowerPoint)
- Documented/Certified training in DMAIC and LEAN concepts a plus.
Education and/or experience
- Bachelor's Degree in Microbiology or Biological Sciences strongly preferred
- Minimum 1-3 years of related work experience; leadership experience is preferred.
- Experience in laboratory, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
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