Quality Analyst - QA Operations (Night Shift)

Takeda•Round Lake, IL

3d•$29 - $46•Onsite

About The Position

The Quality Analyst supports manufacturing operations by ensuring compliance with procedures and regulatory requirements on the production floor. The role investigates and escalates issues in a timely manner to support uninterrupted production, manages samples and sample shipments, and performs quality operations activities including triage, deviation and CAPA initiation and investigation, raw material investigations, QOTSF review and program management, online batch documentation review, and serving as a process subject matter expert. The position supports manufacturing through material and product controls, review and release of pre-printed manufacturing materials, collection and submission of rinse and bioburden samples, batch record documentation review, approval of OSI PI reports, scanner card management, and label copy control and issuance. It also maintains the label cage in a GMP state, operates and maintains quality operations equipment, supports conformance protocols, trains colleagues, and contributes to process efficiency, problem solving, cost savings, quality improvement, and new product support. The role maintains data integrity and compliance with company procedures and applicable regulatory requirements and supports regulatory audits as needed. This is an indoor manufacturing-site role involving a combination of sedentary work and walking around the facility. Work may involve moving machinery, controlled environments and gowning, confined areas, and clean room or cool/hot storage conditions. The role may involve exposure to cephalosporin. The scheduled shift is a 2-2-3 rotation from 6:00 p.m. to 6:30 a.m., with weekends and holidays and overtime as needed to support 24/7 manufacturing operations.

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 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.
Ability to lift, push, pull, and carry up to 50 pounds without material-handling equipment, and push or pull pallets using material-handling equipment.
Ability to stand and/or walk for extended periods during an 8–12-hour shift, between rooms and across the site.
Ability to perform bending, twisting, overhead reaching, squatting, and repetitive hand, wrist, head, knee, and waist motions.
Ability to work around moving equipment and machinery, in confined spaces or areas, and in controlled environments requiring safety gear or gowning; comply with restrictions on makeup, jewelry, nail polish, and artificial fingernails in manufacturing areas.
Must not be allergic to cephalosporin.
Ability to work the 2-2-3 shift (6:00 p.m.–6:30 a.m.), including weekends and holidays as needed, and work overtime as required.
Ability to speak, read, and write English and follow detailed written and oral instructions.

Nice To Haves

Experience in pharmaceutical manufacturing of sterile drug 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, and investigate and escalate issues in a timely manner.
Manage sterility, stability, and other samples; prepare sample shipments; and manage appropriate storage and disposal of retention and reserve samples.
Complete investigations into process failures and raw materials deemed out of specification.
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, trend observations for the monthly quality council, manage the QOTSF program, and initiate JDE work orders if required.
Perform returned-goods, product-hold, and tagging or untagging activities for non-conforming material in a timely manner.
Move materials and products physically and electronically for quarantine and reject areas; use PIT/forklift equipment when trained.
Review and release pre-printed materials to manufacturing in accordance with 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, and label copy control and issuance.
Maintain the pre-printed material label cage in a GMP state while following EHS and 5S guidelines.
Operate and proactively maintain quality operations equipment and document maintenance promptly.
Support execution of conformance protocols with appropriate training.
Serve as a subject matter expert and train other members as required.
Maintain data integrity and compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.
Monitor product quality through required visual and functional testing.
Contribute to team efforts to increase efficiency, solve problems, generate cost savings, improve quality, and support new products.
Support regulatory audits as required.