Quality Assurance Specialist I
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Job Description
About the role:
You will provide support for manufacturing processes and quality oversight, identify risks in activities and processes according to regulatory guidelines, and Takeda's quality practices. You will support Electronic Batch Management. Located at our Social Circle, GA manufacturing plant, this is a full-time role reporting to a Quality Assurance Supervisor.
How you will contribute:
Assess and evaluate by analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with others; review electronic batch records, identify nonconformance issues, and participate in investigation and CAPA activities. Provide employee training on relevant areas and SOPs, and submit procedural changes to meet Corporate, Divisional, Plant, and Regulatory Requirements; Oversee audit of reports and participate in QA multi-site projects as a contributor, coordinator or lead.
Minimum Requirements/
Qualifications:
Education and Experience Requirements
Bachelors in Science/Business. In lieu of a degree, 0-3 years experience in Quality with a medical device/pharmaceutical company or other similarly regulated industry; experience with Word, Excel and PowerPoint; knowledge of TrackWise, Delta V, BAS, PLC, EBM, FDA Regulations, and application of GLP and GMP.
Primary Skills, Abilities, and Competencies
Maintain metrics and guide others to meet requirements; analytical and problem solving skills, encourage teamwork and lead decisions.
Complexity and Problem Solving
Knowledge of manufacturing processes; present decisions based on regulations and regulatory trend expertise.
Internal and External Contacts
Partner with Manufacturing, Compliance, QC labs and Technical Services to adhere to meeting requirements of quality and safety of final product.
Important Considerations
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. 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 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; Work around chemicals such as alcohol, acids, buffers and Celite and Aerosil that may require respiratory protection.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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
#LI-MA1
#LI-ONSITE
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.
Locations
USA - GA - Social Circle - Hwy 278
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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Estimated Salary: $20 to $28 per hour based on qualifications.
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