Job Title: Quality Assurance Specialist II
Job ID R0103744
Location Social Circle, Georgia
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. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members.
You will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
How you will contribute:
Job Function and Description
- 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 training to local employees and others on relevant areas.
- Write written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
- Oversee audit of multiple 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 adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required
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
Must be able to maintain metrics and drive team and external partners to meet metrics requirement.
Must have computer experience (knowledge of Microsoft Word, Excel and PowerPoint required
Knowledge of Electronic Quality Systems (TrackWise), Process control
Systems (Delta V, BAS, PLC), Electronic Batch Record Management
Must have knowledge of FDA Regulations, Application of Good Laboratory
Practice, and Application of Good Manufacturing Practices.
Other Job Requirements
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,.
Work around chemicals such as alcohol, acids, buffers and Aerosil that may require respiratory protection.
May work weekends, evenings, off-hours, and extended periods of time.
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 reimbursement
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:
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.
Takeda Quality Assurance Specialist Takeda Quality Assurance Specialist
