Sr. Quality Assurance SpecialistSocial Circle, Georgia
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
About the role:
The incumbent will write and execute validations and/or protocols for manufacturing processes and laboratory instruments and methods.
How you will contribute:
- May serve as a mentor to other Quality Laboratory positions. Provide training and work direction for Laboratory technicians as required. Manage workflow and laboratory release functions in specified laboratory areas and on off shifts.
- Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
- Use sophisticated laboratory instrumentation and computer systems to collect, analyze and record data.
- Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
- Work on special project/protocol testing that involves new methods and instrumentation. Complete all testing, including special project/protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. Investigate deviations and write exception documents.
- Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
- Perform laboratory and manufacturing audits as required. Audit and update, as required, SOPs.
- Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.
- Work with minimal Supervision.
What you bring to Takeda:
Education and Experience Requirements
Bachelor's degree in chemistry, biological science, or biological science with a minimum of 7 years of related experience or a Master’s Degree in Chemistry or biological science with 3-5 years’ experience
Key Skills, Abilities, and Competencies
- Proficient in wet and instrumental methods of analyses.
- Advanced laboratory skills and basic knowledge of statistical method.
- Strong technical problem solving skills
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must communicate effectively (verbal and written) with supervisors and peers.
- Must demonstrate effectiveness in ability to train others
- Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment
- Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Knowledge of basic chemical and biological safety procedures.
- Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
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:
- 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.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
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.
This posting excludes Colorado 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.
LocationsUSA - GA - Social Circle - Hwy 278
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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