Quality Assurance Specialist II - Filling
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Job Description
About the role:
Come join Takeda where you will provide Quality support and oversight to Filling Operations; Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines and quality practices. This is a role that reports to the Quality Assurance Supervisor at our Social Circle, GA manufacturing facility.
How you will contribute:
- Leads ongoing daily departmental operations (batch record review, floor auditing).
- Provide on-the-floor support to filling activities in an ISO 8 environment. Oversee the aseptic techniques performed by manufacturing inside and outside of the filling isolator.
- Will work with other personnel to achieve defined quality goals and perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
- Determine the logic, adequacy and effectiveness of processes and related requirements and develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
- Write and analyze written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant Regulatory Requirements.
- Support external audits and assist with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions)
- Be a Subject Matter Expert (SME) and provide training to local employees on relevant area(s) and perform other duties, tasks or projects as assigned.
Minimum Requirements/
Qualifications:
Education:
Bachelor's degree in the life sciences, engineering or other related technical field and experience with a pharma/ medical device or other similarly regulated industry.
Experience:
Minimum of three (3) years of experience in biopharmaceutical industry.
Key Skills, Abilities, and Competencies:
- Must be a team player with good problem solving skills and communicate well.
- Can guide decisions based on regulatory knowledge.
- Must have the ability to manage people, encourage teamwork and lead decisions.
- Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Must have computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V)
- Must demonstrate understanding of complex manufacturing processes and make risk-based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.
Complexity and Problem Solving
Decision-making and problem solving include escalation of alerts and triages for on the floor deviations.
Internal and External Contacts
Work with manufacturing, engineering, and quality systems group as primary job responsibility.
Other Job Requirements
Can work swing shift, some weekends, and holidays to support manufacturing.
THIS ROLE/SHIFT IS 4 DAYS A WEEK, 6AM-4:30pm, TUESDAY-FRIDAY.
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 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 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.
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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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