What are the responsibilities and job description for the Quality Operations Supervisor position at Takeda Pharmaceutical?
Quality Operations Supervisor
The Quality Operations Supervisor is responsible for overseeing the day-to-day activities related to the Quality Assurance Operations team.
About the Role:
- Supervises a team of Quality Technicians and Quality Analysts, ensuring they meet performance objectives.
- Owns and approves Standard Operating Procedures and other Quality Documentation relevant to the Quality department.
- Develops and delivers training materials on Quality operations, approving materials pertinent to all areas of the plant.
- Owns investigations and CAPAs related to quality issues, approving those pertinent to the entire facility.
- Approves change controls for compliance with existing requirements.
- Reviews and approves labeling artwork and specifications for packaging material using artwork management software.
- Leads Quality project teams, presenting project plans, progress, and risks to plant management. Represents the organization to regulatory bodies.
- Reviews manufacturing processes for cGMP compliance on the shop floor.
- Reviews and approves raw materials according to standard operating procedures, releasing them for manufacturing use and resolving any related issues.
- Participates in internal and external regulatory audits as a Subject Matter Expert for Quality operations.
- Responsible for AQL and QOTSF program trending, escalating as required for Round Lake site and presenting data to the Quality Council.
- Experience with visual inspection and AQL processes related to parenteral drugs is preferred.
- Knowledge of manufacturing processes related to aseptic filling, visual inspection, and packaging.
- Familiarity with FDA Regulations and Good Manufacturing Practice.
- Demonstrates strong leadership, influence, and cross-functional collaboration skills, working efficiently in a cross-functional team environment.
- Prioritizes tasks and thrives in a fast-paced environment.
- Strong interpersonal skills and attention to detail.
- Able to manage multiple projects concurrently.
- Excellent Microsoft Office skills (Word, Excel, Project, and PowerPoint).
What You Bring to Takeda:
- Typically requires a bachelor's degree, preferably in science, engineering, or a related technical field.
- 4 years of related work experience.
Important Considerations:
In this role, you may be exposed to Cephalosporin drugs. Ability to walk 1-3 miles and lift 10 lbs during a workday is required. The work environment includes indoor conditions, potential exposure to chemicals, and special gowning requirements. May work non-traditional hours, including weekends and holidays.
