Quality Analyst - QA Operations (Night Shift)

Takeda Pharmaceutical; Round Lake (IL); On-site; USD 40,000 - 63,000; Full time

Job summary

Takeda Pharmaceutical Co. in Round Lake, IL is seeking a Quality Operations professional to support on-floor compliance with cGMP/GDP standards and to perform investigations, triage on-floor issues, and CAPA initiation to ensure uninterrupted production.

You will manage samples (sterility, stability), retention samples, and batch documentation, while supervising document revisions and SME training. May work an 8–12 hour shift and lift up to 50 lbs as needed.

Qualifications

• Experience in GMP/GDP environments and regulatory compliance.
• Ability to perform floor investigations and deviations (CAPA).
• Proficient in sample management and batch documentation review.
• Must be able to lift up to 50 lbs and work long shifts (8–12 hours).

Responsibilities

• Ensure compliance with procedures and regulatory requirements on the floor.
• Investigate and escalate floor issues to maintain uninterrupted production.
• Manage sample handling and shipments of retention samples.
• Revise procedures, forms, and specifications as needed.
• Review batch documentation and OSI PI reports for accuracy.
• Serve as SME and train others; maintain data integrity.
• Support regulatory audits as required.

Skills

Communication skills

Problem solving

Attention to detail

GMP/GDP knowledge

Education

High School Diploma or GED with 4+ years experience

Associates degree or higher and 2+ years related experience

Tools

JDE

EBM

TW workflows

Systech

LMS/DMS

MS Word

MS Excel

Outlook

SharePoint

Job description

Job Description

The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You will be responsible for investigations and escalation on the floor in a timely manner to continue uninterrupted production. You will be 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 serve as an SME for processes.

· Responsible for sample management (Sterility, stability, etc.) to appropriate facilities and responsible for the 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. QOTSF review of checklists and trending of observations for monthly quality council. 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 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 a laboratory.

Oversee Manufacturing support activities, including batch record documentation review, approval of OSI PI Reports, scanner card management, label copy control and issuance.

· 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.

Typically Requires:

• High School Diploma or GED with 4+ years of related work experience or an Associates degree or higher and 2+ years 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, and application of cGMP/GDPs

• In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.

• Must be able to lift, push, pull, and carry up to 50 lbs without material handling equipment, and push or pull pallets of material with 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.

• 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.

• Must be able to work 2-2-3 shift (6:00pm – 6:30am), 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.

• Must be able to work overtime as required.

• Must be able to speak, read, write, and follow detailed written and oral instructions in English

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:

$28.99 - $45.53

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.

For information about our benefits, please click here.

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

Job Exempt

No