Quality Assurance Specialist ISocial Circle, Georgia
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.
This position reports to Shift E (Weekend Nights), which includes a shift allowance according to the shift schedule. This shift schedule is Friday - Sunday from 6 pm to 6:30 am and one 8-hour day during the week. This shift requires working on all company-designated holidays. Due to business needs, on select occasions, employees may be required to work overtime and/or support operations on an alternate shift. The company reserves the right to adjust your shift schedule or location if necessary.
About the role:
You will provide Quality Assurance support for Manufacturing process / Important utilities and providing 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. Provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members.
The incumbent will be responsible for, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
How you will contribute:
Responsible ongoing, daily departmental Quality Assurance support for Manufacturing process / 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 groups.
Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
Review electronic batch records, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA) activities
Provide coaching to local employees and others on relevant area(s).
Write, review and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
Oversee, review, and audit of various reports (Protocols, Qualifications, Regulatory Submissions.)
Participate in QA multi-site projects in the role of contributor, coordinator or lead.
What you bring to Takeda:
Education and Experience Requirements
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 have the ability to encourage teamwork and guide decisions.
Must have computer experience
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.
Key Skills, Abilities, and Competencies
Will maintain metrics and guide team and external partners to meet metrics requirements
Analytical and problem solving skills.
Must have the ability to encourage teamwork and guide decisions.
Must have knowledge of FDA Regulations, Application of Good Laboratory
Practice and Apply Good Manufacturing Practices.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
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 artificial fingernails while in the manufacturing environment.
Work multiple shifts including off hours, weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Aerosil that may require respiratory protection.
May be required to 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 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.
This posting excludes Colorado applicants.
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.
LocationsUSA - GA - Social Circle - Hwy 278
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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