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Quality Assurance Specialist II

Social Circle, Georgia
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0125683 Date posted 06/14/2024 Location Social Circle, Georgia

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Job Description

About the role:

Come join us and provide QA support for the manufacturing process/utilities and quality oversight and manufacturing support. You will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines, and Takeda quality practices; 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. You will report to a Supervisor, Quality Assurance at our Social Circle, GA manufacturing facility. This is a weekend nights shift (6pm-630am) plus every other Monday (8 hours).

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 production supervisors, engineering, and other internal groups. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
  • Review electronic batch records, identify non-conformances and participate in investigation and Corrective and Prevention Action (CAPA) activities.
  • Write and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet corporate, divisional, plant, and regulatory requirements.
  • Oversee review of reports (Protocols, Qualifications, Regulatory Submissions)
  • Participate in QA multi-site projects as contributor, coordinator or lead.
  • Maintain metrics and guide team and external partners to meet metrics requirements.
  • Encourage teamwork and guide decisions. Provide coaching to local employees and others on relevant area(s).
  • Demonstrate an understanding of manufacturing processes and make decisions based on knowledge of regulations and regulatory trends. Work with manufacturing, compliance, QC laboratories and technical services to ensure meeting the requirement of quality and safety of final product.

What You Bring To Takeda:

  • 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 articulate, a team player and have good problem solving skills.
  • Knowledge of TrackWise, Delta V and Electronic Batch Record Management.
  • Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Knowledge of Microsoft Word, Excel and PowerPoint required

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:

  • 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.
  • Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
  • May work in a cold, hot or wet environment.
  • May work multiple shifts, including weekends, or be asked to work supplemental hours.
  • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
  • May work weekends, evenings, off-hours, and extended periods of time.

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.

#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:

$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 employees may be eligible for short-term and/or long-termincentives. 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
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Social Circle, Georgia


View Map of Social Circle, Georgia

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