Job Description

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Shift 2 (Swing): This position reports to Swing (2) shift. This shift schedule is Monday-Friday from 2:00 PM to 10:00 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

About the role:

You will help operate 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.

Responsible for timely release of production lots for fractionation, IG and Albumin.

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. Interacts frequently with functional peer, and provide coaching and development of your team. You will demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving.

How you will contribute:

Responsibilities:

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 promptly

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

Provide coaching to local employees and others on relevant area(s).

Write, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed 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.

Other responsibilities, tasks or projects as assigned.

Working Environment:

Will work 8 hour on 2nd shift

What you bring to Takeda:

Education and Experience:

BS in Science / Business or equivalent. 3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.

Knowledge of TrackWise, LIMSand Electronic Batch Record Management

Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Must have the ability to encourage teamwork and lead decisions.

Must have computer experience (knowledge of Microsoft Word, Excel and PowerPoint required)

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 opportunities

Tuition reimbursement

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:

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 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.

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.

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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

Takeda