SR QUALITY ASSURANCE TECHNICIAN

Job Description About the role.
As the Sr Assurance Technician, you will provide Quality Assurance support and oversight for the QC organization.
In providing QA oversight for QC, you will specifically review/approve lab investigations, deviations, SOPs, Analytical Method Validation protocols and reports.
You will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda Quality practices.
You will perform GEMBA's in QC and provide necessary support.
You will demonstrate effectiveness in task completion, decision-making and training investigation writers.
The hours of this position are 12PM-8.
PM, Monday-Friday; weekend and holiday work.
Overtime may be required.
How you will contribute.
Responsible for inspection of production materials, components, and chemicals to the Manufacturing facility.
Based on the business requirement, dispositioning of certain materials, chemical and components, is required upon training completion.
Ensure the laboratory area is maintained in a GMP state while following all EHS guidelines.
Support execution of validations for lab equipment, lab methods and facility projects.
Maintain Data Integrity and ensure compliance with company SOPs, specifications, FDA, cGLP and cGMP regulations.
Navigate Global Supplier Quality Trackwise (GSQ TW), Trackwise 8 (TW 8), JDE and Laboratory Information Management System (LIMS).
Promote continuous improvements through participation (i.
.
team leader/facilitator or major contributor) in the Quality Improvement Program.
May participate in internal and external assessments.
May support Supplier Quality Projects Complete Event tasks in Trackwise 8 Quality Systems.
Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
What you bring to Takeda.
Associate degree in business/scientific discipline and one to three years of relevant experience or Bachelor's degree and no relevant experience..
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,.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
May work flexible hours and overtime on short notice including weekends.
Will operate a forklift, electronic/manual pallet jack within a warehouse environment.
Must be able to carry or lift up to 25 lbs., lift and push/pull > 100 lbs.
with pallet jack.
May work short intervals in cold room environments (-20 C +5 C).
May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.
May gown into clean room environment, don PPE (such as PAPR).
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 #LI-Onsite 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.
.
Hourly Wage Range.
$ The estimated hourly wage range reflects an anticipated range for this position.
The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.
.
based e mployee s may be eligible for s hort - t erm incentives.
U.
.
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.
.
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.