Quality Control Supervisor
- Employer
- Takeda
- Location
- Thousand Oaks, California
- Start date
- Nov 23, 2024
View more categoriesView less categories
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionJob Title: Quality Control Supervisor
Location: Thousand Oaks, CA
About the role:The QC Supervisor is responsible for shaping, and monitoring daily operations, activities, and workflow for the team. You will ensure the implementation of testing standards, policies and ensures safety measures are followed. Additionally, the supervisor supports laboratory personnel with performance, development, feedback and other areas.
How you will contribute:- Provide general oversight by planning, organizing daily laboratory tasks.
- Manage the daily production, scheduling, staffing, material management, compliance, training, and auditing activities.
- Coach and provide feedback to lead personal and team performance.
- Ensure completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation.
- Help 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.
- Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements relevant to pharmaceutical and combination drug manufacturing labs.
- Help with 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, and oversee changes within quality systems.
- Support review of Global documents to ensure local compliance and evaluate gaps within the QC department.
- Assure equipment maintenance and calibration, and internal audits are performed.
- Prepare ,, SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.
- Participate in proactive functions that impact production, increase efficiency, solve problems, create cost savings, improve quality, and provide new product support.
- Individual with demonstrated ability to be a team leader and team player.
- 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.
- 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.
- Experience with programs (including, Excel, and PowerPoint).
- Knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
- Knowledge of quality systems including exception management, change control, document control, etc.
- Knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.
- Write detailed investigation summary memos that meet the requirements of the Quality Organization and the expectations of regulatory agencies.
- Understand how to implement investigation strategies and apply cause failure analysis.
- Bachelor's degree in Biological Sciences of microbiology strongly preferred.
- Minimum 3 years of related work experience; leadership experience is preferred.
- Experience in laboratory, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
- Documented/Certified training in DMAIC and LEAN concepts a plus.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- In general, it's a combination of sedentary work, walking around the lab and supporting the daily activities as needed.
- May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Able to work 4 days a week, 10 hours a day including weekends and possibly holidays.
- May require availability outside regular business hours and/or on-call support.
- Able to work more than a 40-hour work week and adjust shift as needed.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ
#ZR1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CA - Thousand Oaks - Rancho ConejoU.S. Base Salary Range:
84,000.00 - 132,000.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
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.
LocationsUSA - CA - Thousand Oaks - Rancho ConejoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesCompany
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit https://jobs.takeda.com/
- Website
- https://www.takeda.com/
- Location
-
650 East Kendall Street
Cambridge
MA
02421
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert