What are the responsibilities and job description for the Quality Operations Supervisor position at Takeda Pharmaceutical?
About the Role:
The Quality Operations Supervisor oversees daily activities related to the Quality Assurance Operations team.
- Supervise a team of Quality Technicians and Quality Analysts, responsible for their continuous development and performance goals.
- Own Standard Operating Procedures and other Quality Documentation relevant to the Quality department, approving procedures important to all areas of the plant.
- Develop and deliver training materials on Quality operations, approving materials pertinent to all areas of the plant.
- Own investigations and CAPAs relevant to the quality department, approving investigations and CAPAs important to all areas of the plant.
- Approve change controls for compliance with existing requirements.
- Quality approve labeling artwork and specifications for packaging material using appropriate artwork management software.
- Lead Quality project teams and present to plant management project plans, progress, and risks. Represent the organization to governmental regulatory bodies.
- Approve documents following cGMP guidelines and suggest continuous improvement ideas for better processes. Review manufacturing processes for cGMP compliance on the floor.
- Approve raw materials according to standard operating procedures and release them for manufacturing use. Resolve issues related to materials release.
- Participate in internal and external regulatory audits as a SME for Quality operations and present to auditor.
- Responsible for AQL and QOTSF programs trending, and escalation for Round Lake site, presenting appropriate data to Quality Council.
- Experience with visual inspection and AQL processes related to parenteral drugs.
- Knowledge of manufacturing processes related to aseptic filling, visual inspection, and packaging.
- Must have knowledge of FDA Regulations and Application of Good Manufacturing Practice.
Requirements:
- Bachelor's degree in science, engineering, or other related technical field.
- 4 years of related work experience.
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. We must follow strict rules in our manufacturing facilities to ensure we are not endangering product quality.
- You must not be allergic to Cephalosporin drugs.
- Ability to walk 1-3 miles and lift 10 lbs. during a workday is required.
- Indoor working conditions.
- May work around moving equipment and machinery.
- Some Clean Room and cool/hot storage conditions.
- May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body.
- Will need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
- May work in a cold, hot, or wet environment.
- May work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
- Must be able to work aligned shift.
- Can work non-traditional work hours or work extended hours, including weekends and holidays.
About Takeda:
Takeda is transforming patient care through novel specialty pharmaceuticals and the best patient support programs. We are 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.
