Quality Analyst - QA Operations (Night Shift)

Takeda•Round Lake, IL

2d•Onsite

About The Position

The Quality Analyst supports operations by ensuring compliance with procedures and regulatory requirements on the production floor. The role investigates and escalates issues promptly to help maintain uninterrupted production, manages samples and shipments, and supports quality operations and manufacturing activities. The analyst also serves as a subject matter expert (SME), provides training, and supports regulatory audits as required. Responsibilities include sample management for sterility, stability, rinse, bioburden, and retention samples; investigations involving process or raw-material failures; floor triage; deviation and CAPA initiation and investigation; quality risk assessment; QOTSF program activities; and review of batch documentation and manufacturing support records. The role also handles returned goods, product holds, non-conforming materials, quarantine and reject-area movements, pre-printed materials, and quality operations equipment. The analyst maintains data integrity and compliance with company SOPs and applicable FDA, GLP, and cGMP requirements. The position combines sedentary work with walking around the facility and operating in indoor manufacturing environments. It requires physical handling of materials, work around moving equipment, and may involve controlled environments, gowning and protective clothing, confined spaces, clean rooms, and cool or hot storage conditions. The position follows a 2-2-3 schedule from 6:00 p.m. to 6:30 a.m., including weekends and holidays as needed, and may require overtime. This is a full-time, regular, non-exempt employee position in Round Lake, Illinois.

Requirements

High school diploma or GED and at least 4 years of related work experience, or an associate degree or higher and at least 2 years of related work experience.
Effective verbal and written communication skills and strong attention to detail.
Good problem-solving skills.
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Proficiency in Microsoft Word, Excel, Outlook, and SharePoint.
Ability to work with JDE, EBM, TW workflows, Systech, and other LMS/DMS systems.
Ability to speak, read, write, and follow detailed written and oral instructions in English.
Ability to lift, push, pull, and carry up to 50 pounds without material-handling equipment, and to push or pull pallets using material-handling equipment.
Ability to stand and/or walk for extended periods during an 8–12-hour shift and perform required bending, twisting, reaching, squatting, and repetitive motions.
Ability to work a 2-2-3 shift from 6:00 p.m. to 6:30 a.m., including weekends and holidays as needed, and to work overtime and other non-traditional hours as required.
Ability to work around moving equipment and machinery and, when required, in controlled environments, confined spaces, clean rooms, and cool or hot storage conditions.
Ability to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body; manufacturing-area restrictions prohibit makeup, jewelry, nail polish, and artificial fingernails.
Must not be allergic to cephalosporin.

Nice To Haves

Experience in pharmaceutical manufacturing of sterile drugs and/or biologic solutions.
Some knowledge of applicable CTP/SOPs, EHS requirements, FDA regulations, and application of cGMP/GDPs.

Responsibilities

Ensure compliance with procedures and regulatory requirements on the production floor.
Investigate and escalate floor issues in a timely manner to support uninterrupted production.
Manage samples, including sterility, stability, rinse, bioburden, retention, and reserve samples; arrange appropriate storage, shipment, and disposal.
Investigate process or raw-material failures, including out-of-specification materials.
Triage potential floor issues and initiate deviations and investigations when required.
Revise procedures, forms, and specifications as needed.
Identify and assess quality risks in production operations; review QOTSF checklists and trend observations for the monthly quality council; manage the QOTSF program and initiate JDE work orders when required.
Perform returned-goods, product-hold, and non-conforming-material tagging and untagging activities in a timely manner.
Move materials and products physically and electronically to quarantine and reject areas; use PIT/forklift equipment when trained.
Review and release pre-printed materials to manufacturing in accordance with cGMP procedures.
Support manufacturing activities, including batch-record documentation review, OSI PI report approval, scanner-card management, and label-copy control and issuance.
Maintain the pre-printed material label cage in a GMP-compliant state while following EHS and 5S guidelines.
Operate and proactively maintain quality operations equipment and document equipment maintenance promptly.
Support execution of conformance protocols with appropriate training.
Serve as an SME and train other team members as required.
Maintain data integrity and compliance with company SOPs and specifications, FDA, GLP, and cGMP requirements.
Monitor product quality by performing required visual and functional testing.
Contribute to team efforts to improve efficiency and quality, solve problems, generate cost savings, and support new products.
Support regulatory audits as required.