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Job Description

About the role:

As aQuality Associate II at the Takeda Round Lake aseptic pharmaceutical manufacturing facility you will work to perform review and approval of released raw material documentation. You will focus on product quality and compliance through Documentation review (Batch records electronic batch records etc.) Investigation/Change control approvals and Quality oversight of manufacturing processes.

This role is operating on the 2nd shift/Swing from 3:00pm 11:30pm Tuesday-Saturday.

How you will contribute:

• Responsible for driving the Quality on the Shop Floor (QOTSF) program including but not limited to owning managing and approving QOTSF Standard Operating Procedures (SOPs) forms and supporting documents; trending and analyzing shop-floor quality observations; and preparing reports for Quality and Site Leadership.

• Responsible for raw material and bulk container receipts release and investigation if any issues are found. Follow-up with appropriate Takeda facilities for documentation correction in timely manner.

• Manufacturing support activities including batch record documentation issuance of Batch record approval of OSI PI Reports scanner card management management and delivery of test and stability samples label copy control and issuance raw material release in-process work order release and retain sample management

• Back up for the site Stability Program and ensure adequate monitoring of stability sample shipment testing and stability protocol approval. Coordinates with Global Stability on any process changes and responsible for communication and implementation of changes locally.

• Owns Standard Operating Procedures and other Quality Documentation relevant to Quality department. Approves Standard Operating Procedures and other Quality Documentation pertinent to all areas of the plant.

• Develops and delivers training materials relevant to Quality operations. Approves training materials pertinent to all areas of the plant.

• Owns investigations and CAPAs relevant to area of expertise. Approves investigations and CAPAs pertinent to all areas of the plant.

• Approves change controls for compliance to existing requirements.

• Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.

• Leads Quality project teams and presents to plant management project plans progress and risks. Represents the organization to governmental regulatory bodies.

• Review/approve and investigate any JDE inventory management system discrepancies and reach out to appropriate teams to resolve the issues. Utilization of electronic systems such as TrackWise JDEdwards and EBM/C3ME.

• Participate in internal and external regulatory audits as an SME for Quality operations and present to auditor if required.

What you bring to Takeda:

• Typically requires bachelors degree preferably in science engineering or other related technical field.

• 2 years of related work experience

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

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

• Must demonstrate strong leadership influence and cross-functional collaboration skills and be able to work efficiently in a cross-functional team environment.

• Ability to prioritize and thrive in a fast-paced environment.

• Strong interpersonal skills and attention to detail.

• Must be a team player with excellent problem-solving critical thinking and decision-making skills.

• Highly effective verbal and written communication skills.

• Must be able to manage multiple projects concurrently.

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

Important Considerations:

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

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Job Exempt