Quality Assurance Specialist II
Company: Takeda Pharmaceutical
Location: Good Hope
Posted on: May 16, 2022
Job Description:
By clicking the ?Apply? button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda?s and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout the role:As the Quality Assurance
Specialist II, you will support the operation of a new,
state-of-the-art plasma fractionation facility that will bring
Takeda additional capacity for testing, purification and fill
finish for its biologic medications. You will release production
lots for Fractionation, IG and Albumin. You will demonstrate
effectiveness in task completion, empowerment of others, exception
management, training, and problem solving. You will report to the
Supervisor, Quality Assurance.How you will contribute:
- Provide Quality oversight of operation activities, review batch
related document
- Use Electronic Batch Management (EBM) system
- Identify and assess regulatory and quality risks in activities
and processes according to regulatory agency rules and guidelines
and Takeda quality practices.
- Work with functional peer, and provide coaching, training and
development of your team.
- Perform QA Release Function:
- Complete product C of As
- Release production lots based on product specifications
- Update metrics biweekly
- Maintain task Tracker
- Follow up with supporting departments on deliverables
- Identify and escalate issues
- Perform product holds of lots
- Review documentation for accuracy and compliance to procedures
and specifications, and release and reject
- Review electronic batch records, identify nonconformance's and
participate in investigation and Corrective and Prevention
Action(CAPA) activities
- Write, review, analyze and revise written Standard Operating
Procedures (SOPs) and submit procedural changes to meet Corporate,
Divisional, Plant, Regulatory Requirements
- Promote continuous improvements through participation (i.e.
team leader/facilitator or major contributor) in the Quality
Improvement Program.
- Participate in QA multi-site projects in the role of
contributor, coordinator or lead.
- Knowledge of TrackWise, LIMS and Electronic Batch Record
Management preferredWhat you bring to Takeda:
- Typically requires a BS in Science / Business or
equivalent.
- 3+ years of experience in Quality with a medical device/Pharma
company or other similarly regulated industry.
- Can encourage teamwork and drive decisions.
- Have computer experience (knowledge of Microsoft Word, Excel
(can perform complex functions) and PowerPoint
- Have knowledge of FDA Regulations, Application of Good
Laboratory Practices, and Application of 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
- Tuition reimbursementImportant ConsiderationsAt 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.This posting excludes
Colorado applicants.#GMSGQ#ZR1#LI-MA1EEO 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 278Worker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Atlanta , Quality Assurance Specialist II, Other , Good Hope, Georgia
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