Quality Operations Supervisor at Baxalta U.S., Inc. in Round Lake Beach, Illinois

Job Description:

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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 team, 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, etc.), Investigation approvals and Quality oversight of manufacturing processes.You will report to the QA Operations Manager.

How you will contribute:

• Supervise a team of Quality Technicians and Quality Analysts. Responsible for the team's continuous development and ensuring they are meeting performance goals.


• Own Standard Operating Procedures and other Quality Documentation relevant to Quality department. Approve Standard Operating Procedures and other Quality Documentation relevant to all areas of the plant.


• Develop and deliver training materials relevant to Quality operations. Approve training materials relevant to all areas of the plant.


• Own investigations and CAPAs relevant to quality department. Approve investigations and CAPAs pertinent 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.


• Test and review 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, if required.


• Responsible for AQL and QOTSF programs trending, and escalation as required for Round Lake site and present appropriate data to Quality Council.


• Work with supplier for investigations

• Experience with visual inspection and AQL processes related to parenteral drugs is preferred.


• Knowledge of SAR.


• Knowledge of manufacturing processes related to aseptic filling, visual inspection, and packaging.


• Must have knowledge of FDA Regulations and Application of Good Manufacturing Practice.


• Excellent Microsoft Office skills (Word, Excel, Project, and PowerPoint).


• Typically requires bachelor's degree, preferably in science, engineering, or other related technical field.


• 4+ years of related work experience.

• 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

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. In this role, you may:

• The candidate 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.


• May be required to work in controlled environments requiring special safety gear or gowning; will be required to 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/or cool/hot storage conditions.


• Must be able to work aligned shift.


• Must be able to work non-traditional work hours or work extended hours, including weekends and holidays, as needed.

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.

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 - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time