Quality Analyst - Quality Assurance Operations

at Takeda Pharmaceuticals in Round Lake Beach, Illinois, United States

Job Description

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Job Description

Job Title: Quality Analyst – Quality Assurance Operations

Location: Round Lake, IL

About the role:

The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. The incumbent is responsible for investigations and escalation on the floor in a timely manner to continue uninterrupted production. The incumbent is responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities include and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serving as an SME for processes.

How you will contribute:

+ Responsible for sample management (Sterility, stability, etc.) to appropriate facilities and responsible for appropriate storage and disposal of retention samples.

+ Complete investigations in the event of a failure pertaining to processes or Raw Material that is deemed to be out of specification.

+ Triage potential issues on the floor. Initiate deviation and complete investigation, if required.

+ Revise documents to procedures, forms, and specifications as needed.

+ Manage the appropriate storage and disposal of retention and reserve samples.

+ Identifies and assesses quality risk in production operations daily. TIQ/QOTSF review of checklists and trending of observations for monthly quality council. TIQ/QOTSF program management and JDE work order initiation if required.

+ Perform Returned Goods, Product Holds, and Tagging and Untagging of non-conforming material in a timely manner.

+ Responsible for the movement of materials/products physically and electronically for quarantine/reject areas and trained on PIT/forklift to move materials.

+ Review and release pre-printed materials to manufacturing following cGMP procedures.

+ Collect and submit rinse and bioburden samples to the laboratory.

+ Oversee Manufacturing support activities including batch record documentation review, approval of OSI PI Reports, scanner card management, label copy control and issuance, raw material release, in-process work order release, and retention sample management.

+ Ensure pre-printed material label cage is maintained in a GMP state at all times while following all EHS and 5S guidelines.

+ Operate and proactively maintain quality operations equipment. Ensure that equipment maintenance is properly documented in a timely manner.

+ Support execution of conformance protocols with appropriate training

+ Serve as Subject Matter Expert (SME) and provide training to other members as required.

+ Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.

+ Monitor product quality through the performance of required visual and functional testing.

+ Actively contribute to a team setting within the quality operations and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

+ Support regulatory audits as required.

+ Highly effective verbal and written communication and great attention to detail.

+ Good problem-solving skills.

+ Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

+ Proficient in Microsoft Word, Excel, Outlook, and SharePoint.

+ Able to work with JDE, EBM, TW workflows, Systech and other LMS/DMS.

What you bring to Takeda:

Typically Requires:

+ High School Diploma or GED with 4+ years of related work experience or Associates degree or higher and 2+ years of related work experience.

Desired:

+ Experience in pharmaceutical manufacturing of sterile drug and/or biologic solutions, preferred.

+ Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs.

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. In this role, you may:

+ In general, the position requires a combination of sedentary work and walking around observing 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 over an 8-12-hour shift between rooms and across the site.

+ May require bending, twisting, reaching overhead, and/or 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/or contacts.

+ May not be colorblind (Applies to roles performing visual inspection only).

+ Indoor working conditions.

+ Will work around moving equipment and machinery.

+ May be required to work in confined spaces/areas.

+ Some Clean Room and/or cool/hot storage conditions.

+ May be exposed to and must not be allergic to cephalosporin.

+ May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

+ Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

+ May work in a cold, hot or wet environment.

+ May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

+ Must be able to work 2-2-3 shift, including weekends and holidays, to support a 24/7 manufacturing operation as needed.

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

More about us:

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.

\#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:

USA – IL – Round Lake – Drug Delivery

U.S. Hourly Wage Range:

$22.55 – $35.43

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