Job Description

About the role:

The Quality Operations Supervisor oversees the daily activities related to the Quality Assurance Operations team. You will work as part of a teams providing quality leadership and focus on product quality and compliance through Quality on the shop floor (QOTSF), Acceptable Quality Limit (AQL) inspection, Incoming raw materials release, Documentation review (Batch records, electronic batch records), Investigation approvals and Quality oversight of manufacturing processes. You will report to the QA Operations Manager.

How you will contribute:

• Manages a team of Quality Technicians and Quality Analysts. Responsible for the team’s continuous development and ensuring they are meeting performance goals.
• Oversee Standard Operating Procedures and other Quality Documentation relevant to Quality department. Approve Standard Operating Procedures and other Quality Documentation important to all areas of the plant.
• Develop and deliver training materials relevant to Quality operations. Approve training materials important to all areas of the plant.
• Own investigations and CAPAs relevant to quality department. Approve investigations and CAPAs important to all areas of the plant.
• Approve change controls for compliance to existing requirements.
• Quality Approval of 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 appropriate 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 and present appropriate data to Quality Council.

What you bring to Takeda:

• Typically requires bachelor’s degree in science, engineering, or other related technical field.
• 4+ years of related work experience.
• 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.
• You must not be allergic to Cephalosporin drugs.
• Will work aligned shift.
• Will work non-traditional work hours or work extended hours, including weekends and holidays.

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:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• 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.
• 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.
• May work in controlled environments requiring special safety gear or gowning; will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.
• Some Clean Room and cool/hot storage conditions.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is 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.

#GMSGQ #ZR1

How to Apply

Job Types: Full-Time. Salaries: Not Disclosed.

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