Job Description

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Job Description

About the role:

The Senior Quality Analyst is in the QA Line Ops organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. The primary responsibility is to provide on-the-floor manufacturing support for the site's Quality on the Shop Floor (QOTSF) program. Also, supporting QA Line Operations processes, including deviation investigation, CAPAs, assessment for potential issues on the floor, environmental monitoring, aseptic sampling methods, contamination control strategies, Acceptable Quality Limit (AQL) sampling of finished product, sample management, kitting of batches, and batch record documentation. You will report to the Quality operations Supervisor.

How you will contribute:

• Responsible for Quality on the Shop Floor (QOTSF) operations, implementations, and improvements.
• Identify and assess quality risk in production operations daily. QOTSF program are part of manufacturing support and compliance enforcement. Perform QOTSF review of checklists.
• Mentor manufacturing personnel on the floor on aseptic awareness and appropriate cleanroom behaviors. Oversee aseptic manufacturing processes, including cleanroom processes, gowning procedures, and environmental monitoring.
• Perform and support of the bulk sampling processes for bulks shipped to Round Lake from other facilities.
• Oversee Standard Operating Procedures and other Quality System Documentation relevant to their responsibilities/expertise. Approve documents to procedures, forms, and specifications.
• Develop, approve, and deliver training materials relevant to their area of expertise.
• Identify, escalate, and resolve potential compliance and safety issues. Initiate deviations and CAPAs relevant to responsibilities/expertise.
• Monitor product quality through the performance of required visual and functional testing.
• Support Quality Analyst and Quality Technician responsibilities.
• Support regulatory audits.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Contribute to a team setting within the quality and potentially with other work teams to increase efficiency, solve problems, create cost savings, improve quality, and provide new product support.

What you bring to Takeda:

• Typically requires, High School Diploma or GED with 6+ years of related work experience or Associates degree or higher and 4+ years related work experience.
• Proficient in Environmental Monitoring, Microbial sampling, and Sterile sampling techniques.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Work with JDE, EBM, TW workflows, Systech, and other LMS/DMS.
• In general, your work will be a combination of sedentary work and walking around observing the conditions of the facility.
• Will work aligned shift.
• Must be able to 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.
• In general, your work will be a combination of sedentary work and walking around observing the conditions of the facility.
• Must be able to carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of material handling equipment).
• Must be able to stand and/or walk for an extended period between rooms and across the site.
• May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks
• Repetitive motions with hands, wrists, turning head, bending at knees and waist
• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and contacts.
• May not be colorblind (Applies to roles performing visual inspection only).
• Will work around moving equipment and machinery
• Some Clean Room and cool/hot storage conditions.
• May work with and must not be allergic to cephalosporin

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

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. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 job. The actual hourly wage 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 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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