As the largest pharmaceutical company in Asia and among the top 20 largest pharmaceutical companies in the world by revenue, Takeda (NYSE: TAK) is a values-based, R&D-driven biopharmaceutical leader committed to discover and deliver life-transforming treatments to patients globally. Our Purpose - to create better health for people
, and a brighter future for the world
- guides us as we continue to build a workplace supporting future ways of working and the well-being of our employees. Certified as a four-time Top Global Employer
by the Top Employers Institute for Excellence, life at Takeda empowers you to grow in a meaningful career.
The QC Microbiology Supervisor is responsible for planning, organizing and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, this role will implement testing standards, policies and ensure safety measures are followed. The Supervisor will assist laboratory personnel with career development, performance and other areas as needed.
Essential Duties and Responsibilities
- 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.
- May also perform other duties as assigned
- 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.
- The overall physical exertion of this position requires light to medium work.
- May be required to sit between 1-2 hours, walk between 3-4 hours and stand for over 4 hours
- May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours
- May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours
- May be required to lift up to 50lbs between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift
- May be required to carry 5-10lbs up to 30x per shift up to 20ft, 11-25lbs up to 5x per shift up to 5ft, and 26-50lbs up to 5x per shift up to 5ft
- Requires repetitive use of both right and left hands over 4 hours
- May require simple and power grasping between 3-4 hours
- May require fine manipulation up to 1 hour
- May require pushing/pulling with hands/arms between 3-4 hours
- May require office work activities with hands/arms between 3-4 hours in all Quality areas
- May be required to gown frequently and balance when gowning into clean areas
- May be required to work around moving equipment and machinery
- May be required to walk on uneven ground or slippery surfaces
- May be exposed to noise above 85 dBA in Microbiology. This may require hearing protection and other protective equipment to be worn.
- May work and have exposure to hot, cold, wet environment/conditions.
- May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes (may require respiratory protection)
- May require the use of special visual or auditory protective equipment
- May be required to work with biohazards such as: bloodborne pathogens, sewage or medical waste in all Quality areas.
- May be required to work in confined areas.
- Office work environment
- May work in controlled or clean room environments requiring special gowning.
- May support QC analysts in the laboratory as needed.
At Takeda, our global, engaged workforce is committed to continuously innovate on our ways of working to keep our competitive edge and deliver the highest quality therapies to for patients all over the world.
Join us in shaping the future of healthcare. Be empowered to make a difference. Apply now.
Takeda is an equal opportunity employer.
This job posting excludes CO applicants.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
USA - CA - Thousand Oaks - Rancho ConejoWorker Type