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Job DescriptionAbout the role
This position is responsible for providing Quality Assurance support and oversight for the QC organization. In providing QA oversight for QC, this position will specifically review/approve lab investigations, deviations, SOPs, Analytical Method Validation protocols and reports. This position will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda Quality practices.
This position will also be responsible for performing GEMBA’s in QC and provide necessary support. The incumbent will be responsible for handling multiple tasks and demonstrate effectiveness in task completion, decision-making and training investigation writers.
How you will contribute

• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with laboratory supervisors or other involved departments.
• Leads ongoing, daily departmental Quality Assurance support for QC and attend QC meeting to assess the situations and workload.
• Active participant in lab investigations through each step of the process (providing guidance as needed)
• Provide Quality Assurance support and oversight for QC organization. Review and approve documents such as Deviations, SOP’s, LIR’s, OOL’s, OOR, Protocols etc. authored by QC organization.
• Review and approve Analytical Method Validation/Transfer Protocols and Reports
• Participate in problem solving sessions and in rDMAIC’s as needed.
• Attend/participate in daily QC Tier meetings
• Support internal and external laboratory audit readiness efforts.
• Provide training and coaching to local employees and others as needed on relevant area(s).

What you bring to Takeda
Typically requires bachelor’s degree in science, engineering, or other related technical field. 3 years of related experience. Bachelors’ Degree in Chemistry or Biological Science is preferred. Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Knowledgeable of laboratory tests / equipment including the use of statistical method (previous experience in GMP QC lab is a plus)
• Strong problem-solving and analytical skills are required.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Must have good organizational, verbal and written communication skills; able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
• Self-driven individual that requires minimal supervision
• Knowledge of basic chemical and biological safety procedures.
• Understanding of manufacturing and facility processes.
• Demonstrate technical writing skills (e.g. investigation reports) and the ability to seek and identify solutions.
• Demonstrate effectiveness in supporting continuous improvement and promoting the control and prevention of potential issues.
• Good computer skills, knowledge of Microsoft Word, Excel, and PowerPoint.
• Work with minimal supervision.

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 be required to 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/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.
#GMSGQ #ZR1
Takeda Compensation And Benefits SummaryWe 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 $84,000.00 - $132,000.00
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 employees may be eligible for short-term and/ or long-term incentives. 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 StatementTakeda 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
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time