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Job Description Quality Assurance Specialist II About the role:
As a Quality Insurance Specialist II, you will provide Quality Assurance support for Manufacturing process, Critical utilities, provide Quality oversight, and manufacturing support. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members. You will be responsible for multiple projects, demonstrate effectiveness in task completion, empowerment of others, exception management, training, problem solving and team leadership.
The hours of this position are 10AM-6:30PM, Monday-Friday; weekend and holiday work. Overtime may be required.
How you will contribute:
- Responsible ongoing, daily departmental Quality Assurance support for Manufacturing process or Critical utilities.
- Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with Production Supervisors, Engineering, and other internal departments.
- Release production lots based on product specifications
- Update metrics biweekly and maintain task Tracker
- Follow up with supporting departments on deliverables
- Identify and escalate issues and perform product hold of lots.
- Review documentation for accuracy and compliance to procedures and specifications, and release and reject.
- Review electronic batch records, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA) activities
- Provide training to local employees and others on relevant area(s).
- Write and analyze written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
- Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.
- Participate in QA multi-site projects in the role of contributor, coordinator or lead.
What you bring to Takeda:
- Typically requires Bachelors in Science / Business. In lieu of degree, 3+ years experience in Quality with a medical device/Pharma company or other similarly regulated industry.
- Must be a team player
- Encourage teamwork and guide decisions.
- Will maintain metrics and lead team and external partners to meet metrics requirements
- Analytical and problem solving skills
- Knowledge of Microsoft required
- Knowledge of Track Wise and Electronic Batch Record Management
- Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
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. In this role, you may:
- May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
- 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, and extended periods of time.
- 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.
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 - GA - Social Circle - Hwy 278
U.S. Base Salary Range:
$67,900.00 - $106,700.00
The 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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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.
Locations USA - GA - Social Circle - Hwy 278
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
