Sr Quality Assurance Specialist

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Job Description

About the Role :

The position is responsible for Quality oversight of both the Packaging and Visual Inspection Operations, supporting daily operational meetings and production activities. Incumbent will be required to partner with Manufacturing, Engineering, Maintenance, and Manufacturing Sciences teams.

How you will Contribute :

The position is responsible for Quality oversight of both the Packaging and Visual Inspection Operations, supporting daily operational meetings and production activities. Incumbent will be required to partner with Manufacturing, Engineering, Maintenance, and Manufacturing Sciences teams.

Will write, review, analyze and revise written Standard Operating Procedures (SOPs) and support development and review of Protocols, Qualification, Regulatory Submissions, etc.

Perform ongoing daily departmental activities related to deviation management and aid any issues tied to product disposition, including timely batch record reviews to ensure on time release of batches.

Develop plans to correct identified risks including areas of non-conformance and approve and device strategy to implement effective CAPA’s.

Responsible for technical review and approval of Non –Conformance investigations including deviations and Change Control records.

Responsible for supporting Customer Complaint investigations with inspection of retention samples and returned product.

Process the closure of Non- Product lot related investigations, extension requests and commitment records in the Trackwise database.

Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Quality requirements.

Participate in external assessments and audits by evaluating and solving product / process problems by providing technical, analytical, and supervisory skills.

Must be able to support manufacturing operations in lieu of absent personnel by maintaining all required qualifications.

Leads ongoing, daily departmental operations.

May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner

Evaluate, train and develop VI & Packaging QA team.

Provide quality oversight for packaging operations, including control of printed materials, visual inspections, verification of labels and product packaging, perform AQL inspections, Batch Record review- meeting requirements of CFR 21.

Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

Serve as Subject Matter Expert (SME) and provide training to local employees as needed on packaging compliance

Other duties, tasks, or projects as assigned

What you bring to Takeda :

Associates degree in business / scientific discipline and one to three years of relevant experience preferred.

Bachelor’s degree in the life sciences and experience with a medical device / pharma or other similarly regulated industry preferred

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 :

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 / 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  #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.S. Base Salary Range :

$86,500.00 - $135,960.00

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 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

Job Exempt

Yes