Quality Management Specialist
Full-time
Global Life Science Hub
QMS Specialist - Biologics Manufacturing
Chicago, IL
On-site | Full-time, Permanent
Global Life Science Hub is supporting a growing commercial-stage biologics manufacturer looking to expand its Quality Systems team in Chicago.
We are looking for a QMS Specialist with experience directly supporting GMP biologics manufacturing , ideally across upstream and/or downstream operations.
Key Responsibilities
- Own and support deviations, CAPAs and change controls through investigation and closure
- Conduct root cause investigations using tools such as 5-Why and 6M
- Review GMP batch records and manufacturing documentation
- Support Quality events arising from upstream and downstream manufacturing
- Create, review and revise SOPs
- Partner closely with Manufacturing, QA, QC and technical teams
- Support inspection readiness and continued QMS compliance
Requirements
- 2+ years of Quality/QMS experience within GMP pharmaceutical or biologics manufacturing
- Experience directly supporting upstream and/or downstream biologics manufacturing
- Strong hands-on experience with deviations, CAPAs, change controls and investigations
- Experience reviewing GMP manufacturing batch records
- Strong understanding of cGMP requirements
- Ability to work full-time on-site in Chicago
Highly Relevant Experience
- Mammalian cell culture / bioreactor operations
- Chromatography / purification
- TFF / UF-DF / filtration
- Commercial biologics or biosimilar manufacturing
- TrackWise, Veeva or similar eQMS platforms
If you have a strong QMS background within biologics manufacturing and are open to a new opportunity in Chicago, please apply or reach out directly.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Quality Management Specialist in Chicago, IL vacancy
- ...Job Description QMS Specialist - Biologics Manufacturing \n Chicago, IL \n On-site | Full-time, Permanent \n \n Global... ...commercial-stage biologics manufacturer looking to expand its Quality Systems team in Chicago. \n \n We are looking for a QMS...SuggestedPermanent employmentFull time
Global Life Science Hub
Chicago, IL5 days ago - ...Gilero, a Sanner Group company, is seeking an experienced Quality Operations Specialist to support our Pittsboro, NC facility. You will be responsible... ...of controlled environment areas per internal procedures Manage third-party environmental testing and approve results...SuggestedContract workTemporary workImmediate start
Gilero
Chicago, IL2 days ago $82.7k - $120k
...Information We CollectYour Privacy ChoicesTeam OverviewThe Data Performance team is part of Data Asset Management within Global Operations and is responsible for improving the quality, performance, and value of TransUnion’s data assets. The team monitors data quality throughout...SuggestedFull timeTemporary workWork experience placementWork at officeFlexible hours2 days per weekTransUnion
Chicago, IL2 days ago- ...Job Title: Lead QA Specialist Location: Chicago, IL or Peoria, IL Let's create... ...Seeking a Lead QA Specialist / IT Quality-Test Engineer 5 to join its Quality Assurance... ..., test planning, automation, defect management, and quality assurance activities across...SuggestedLocal area
The AES Group
Chicago, IL3 days ago - ...Contributions to Work Group : \n - We are looking for a Lead QA Specialist to join our Quality Assurance team. The quality assurance team is working... ...leading relentless pursuit of quality including defect management on multiple large-scale programs for the Client Digital...SuggestedWork at officeLocal area
DSM-H Consulting
Chicago, IL3 days ago - ...Job Description Job Description Quality Manager & Lead Auditor (Metal Plating Company) Our client, a leading provider of electroless... ...consideration. \nCompany Description We are employment specialists who have worked in heath care and managed care industry for...Temporary workImmediate start
Managed Care Staffers
Chicago, IL23 days ago - ...be proficient with testing methodologies preferably iterative approach. Candidate must have experience with QA testing tools like Quality centre and Jira. Candidate must be proficient with SQL,UNIX/LINUX 3 years of experience testing ETL workflows (Informatica) Candidate...
System Canada Technologies
Chicago, IL20 hours ago - ...of FIX protocol (preferably FIXML) Strong API testing experience using Sonic JMS / IBM MQ / Knowledge on test and defect management tools ( Quality Center, Jira ) Strong knowledge of SQL and able to write queries to verify data in Oracle DB Experience with end to end...
System Canada Technologies
Chicago, IL1 day ago $21 - $25 per hour
...Quality Specialist Nosco is looking for a Quality Specialist on second shift at our Bridgeview, IL facility. As an employee owner in this... ...the color standard library. As directed by the QA Manager or Quality Engineer, facilitates and/or oversees the root cause...Hourly payFull timeTemporary workFlexible hoursAfternoon shiftNosco
Bridgeview, IL4 days ago$110k - $150k
...litigation. 4. Exceptional legal research and writing skills. 5. Strong negotiation and advocacy skills. 6. Demonstrated ability to manage multiple projects, prioritize tasks, and meet deadlines. 7. Excellent interpersonal and communication skills, with the ability to...Permanent employmentLocal areaFlexible hoursJobot
Chicago, IL2 days ago- Reporting to the Food Safety Quality & Regulatory Affairs Manager, you will provide strategic Food Safety Quality & Regulatory Affairs leadership across a portfolio of contract manufacturing partners. You will drive risk identification and mitigation, influence food safety...Full timeContract workWork at officeLocal areaFlexible hours
Conagra Brands
Chicago, IL1 day ago $40.5 - $64.8 per hour
...~ Paid time off and Holiday pay Description The Quality Utilization Specialist reflects the mission, vision, and values of NM, adheres... ...liaison with the clinical care team assuring compliance with managed care contracts and payor guidelines while maintaining...Hourly payFull timePart timeFor contractorsWork experience placementWork at officeLocal areaRelocation packageFlexible hoursNorthwestern Memorial Hospital
Chicago, ILa month ago- ...Guidehealth, a remote-first healthcare company, is hiring a Remote Clinical Quality Improvement Coordinator to drive quality initiatives and patient outreach across payers and providers. You will access EMR data, claims, and outreach to close quality gaps while collaborating...Remote work
Guidehealth
Chicago, IL1 day ago - U.S. Department of Veterans Affairs at Edward Hines - Jr. VA Hospital seeks a Health System Specialist (GS-11) to advance high reliability and quality improvement across the Medical Center. The role focuses on program analysis, coordination with safety and improvement...
- ...decisions and client outcomes. You will translate business questions into clear analysis and manage a high volume of requests. You will perform ad hoc reporting, data validation, and quality checks, partner with stakeholders, and help drive automation. Proficiency in SQL and...
$104.8k - $131k
...OnTrac is hiring a Quality Assurance Consultant ! Are you eager to join a dynamic and expanding company where you can both learn... ...accurately. May conduct site assessments, lead investigations, and manage documentation and reporting of quality metrics to support...Work at officeRemote workHome officeMonday to FridayShift workOnTrac
Chicago, IL4 days ago$20 per hour
PeopleShare by PROMAN in Woodridge, IL is seeking a Warehouse Quality Control Associate to join a growing distribution and manufacturing facility. The role focuses on inspecting products, maintaining quality standards, and supporting warehouse operations in a fast-paced...Hourly payTemporary workMonday to Friday$23 - $28 per hour
...data is used in clinical settings. We are looking for a Senior Quality Assurance Associate or Quality Assurance Associate who will be... ...assurance activities in accordance with FDA QMSR (Quality Management System Regulation), ISO 13485, and other applicable global regulations...Full timeWork at officeShift workTempus
Chicago, IL2 days ago- ...Job Description Job Description As a Quality Auditor, you will ensure that manufactured goods meet customer requirements and quality... ...inspecting products and reporting findings to the Production Manager. It is ideal for individuals detail-oriented and committed to maintaining...Temporary work
Ron's Staffing Services Inc
Alsip, IL9 hours ago - ...Career Opportunities: Quality Assurance Specialist (4916) KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection... ..., you’ll work closely with the Quality Assurance Manager and center leadership to monitor compliance, review documentation...Work at officeLocal area
KEDPlasma USA
Chicago, IL2 days ago $55k - $70k
...Quality Assurance SpecialistPassionate about precision medicine and advancing the healthcare... ...Sunday-Thursday.The Quality Assurance Specialist plays an integral role in supporting... ...assigned.Responsible for processing and managing issues/incidents that include deviations...Weekend workTempus
Chicago, IL1 day ago- ...Term Life Insurance Plan Standard Disability Plan QUALITY ASSURANCE SPECIALIST Job Description: The Quality Assurance (QA) Specialist... ...Perform individual or group projects assigned by the QA Manager. Collect samples of ingredients, perform quality checks...Local areaImmediate startVisa sponsorship
Batory Foods
Chicago, IL4 days ago - ...Job Description Front-Office Risk Data Quality Analyst \n Company Overview \n Business Integration Partners (BIP) is Europe... ...supplemented with Data & AI, Cybersecurity, Risk & Compliance, Change Management and Digital Transformation practices. We integrate deep...Temporary workRemote workWorldwide
BIP US
Chicago, IL10 days ago - ...is a technology platform transforming energy procurement and management for enterprises, energy advisors, and suppliers. Our platform... ...seeking a highly motivated and experienced QA Analyst to help drive quality across our growing SaaS platform. In this role, you will lead...
Power Kiosk
Chicago, IL2 days ago - ...Nursing Quality Specialist In The Nicu Department Join us at the forefront, at UChicago Medicine, as a Nursing Quality Specialist in the... ...Specialist, your role will be responsible and accountable to manage strategic execution of a portfolio of projects aligned with strategic...Full timeShift work
$23 - $35 per hour
...are seeking a detail-oriented and customer-focused Field Quality Control Specialist and a Lead to ensure the highest standards are upheld on residential... .... That looks like training that actually prepares you, managers who coach instead of just assign, and clear paths to grow....ApprenticeshipLocal area$120k - $140k
...Job Description Backend Quality Assurance Specialist – Chicago, IL (Hybrid) \n Salary: $120,000 – $140,000 base + discretionary annual bonus... ...across the core Exchange, Clearing and Instrument management systems, extending the QA automation framework and building...Full timeE-Frontiers
Chicago, IL9 days ago$58 - $62 per hour
...executing formal test plans/test scripts to ensure the delivery of quality software applications or data repository releases. \n \n... ...(UAT)\n Work closely with software developers, product managers, and other QA team members to understand product specifications...Remote jobHourly payContract workIT Associates
Chicago, IL6 days ago- ...Job Description Quality Assurance (QA) Analyst \n \n Who We Are \n Renovo Financial is a dynamic and fast-growing private... ...documents to remedy exception items in TPR portal \n \n Exception Management & Monitoring \n \n Daily Data exports to sort/monitor...Work at office
Renovo Financial
Chicago, IL10 days ago $20 - $40 per hour
...We are dedicated to open source software solutions by providing managed services for Drupal-based websites, products, and applications.... ...basis, remotely. The QA team member is responsible for leading quality review of various applications. The role relies upon test...Hourly payPart timeWork experience placementLocal areaRemote work10 hours per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Management Specialist. Be the first to apply!
Related searches
- quality auditor Chicago, IL
- quality systems specialist Chicago, IL
- warehouse quality control associate Chicago, IL
- quality assurance auditor Chicago, IL
- quality specialist Chicago, IL
- quality associate Chicago, IL
- quality system auditor Chicago, IL
- quality review specialist Chicago, IL
- quality control associate Chicago, IL
- quality management specialist Chicago, IL