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Quality Analyst - QA Operations

Employer
Takeda
Location
Round Lake, IL
Salary
None
Start date
Jan 25, 2023

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Job Details

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Job Description

About the role:

The Quality Analyst - QA Operations reports to the QA Operations Manager. Your primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for raw materials, facilities and manufacturing processes investigations and escalation on the floor in a timely manner to continue un-interrupted production. The incumbent is accountable for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities include triage for potential issues on the floor, Deviation/CAPA initiation and investigation, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, and serve as an SME for processes.

How you will contribute:

  • Handles sample management (Sterility, stability, etc.) on site and for the logistics of shipping samples to appropriate facilities for appropriate storage, testing and for 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.

  • Perform triage with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate if required. Initiate deviation and complete investigation, if required.

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

  • Identifies and assesses quality risk in production operations daily. Quality on the Shop Floor (QOTSF) and Total Integrated Quality (TIQ) programs are part of manufacturing support and compliance enforcement. Perform TIQ/QOTSF review of checklists and trend observations for monthly quality council. TIQ/QOTSF program management and Initiation of JDE (inventory management system and preventive maintenance system) work orders if required.

  • Perform returned goods, product holds, and tagging and un-tagging of non-conforming material in a timely manner.

  • Performs and coordinates 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 laboratory following cGMP.

  • Review 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 completion of appropriate training.

  • Subject Matter Expert (SME) and provide training to other employees as required.

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

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

  • Actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

  • Support regulatory audits as required.

What you bring to Takeda:

  • Good interpersonal skills and ability to work effectively and efficiently in a team environment.

  • Highly effective verbal and written communication.

  • Good problem-solving skills and great attention to detail.

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

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

  • Competent with JDE, EBM, TW workflows, Systech and other LMS/DMS

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

What Takeda can offer you:

  • 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

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.

  • Indoor working conditions.

  • Will 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.

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

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

  • Must be able to work a 12-hour shift (6:00am – 6:30pm or 6:00pm – 6:30am), in a 2-2-3 rotation, including weekends and holidays, to support a 24/7

  • Must be able to work overtime as required.

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.

This posting excludes Colorado applicants.

#ZR1
#GMSGQ
#LI-MA1

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

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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