QA Compliance Specialist II
Spectraforce Technologies Inc
Position Title: QA Compliance Specialist IIWork Location: 60064, North Chicago, ILAssignment Duration:Work Arrangement: Onsite (warehouse floor support required)Position Summary: Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy. Assess operations/distribution outages and deviations to determine compliance with specifications and procedures.Key Responsibilities:
- Site CAPA Coordinator/ administrator for shipment temperature management
- Audit Interface- FDA, supplier, customer inspection, corporate
- Project Management for Quality Initiatives
- Manage Validation Library
- Conduct product quality, diversion and distribution complaint investigations
- Manage warehouse temperature monitoring program
- Point Person for NPI launches
- Execute placement and removal of QA Holds in warehouse management system
- Manage/Post supplier audit data in appropriate database
- Manage market authorization process and Master Data ManagementQualifications & Experience:
- Bachelor’s degree is preferred
- 4 years in Quality Assurance, Process Support, Engineering, Manufacturing/Operations, Distribution or similar area.
- Reviewing problem solving situation
- Understand manufacturing / distribution process
- Product responsibility for compliance troubleshooting
- Audit interface
- Creativity in resolving issues
- Negotiation skills with Mfg. / Distribution customers
- Individual is also heavily involved in the analysis of complex technical data in all aspects of product acceptance. This position is heavily involved in product and process problem solving and works closely with R&D, Process Development, Manufacturing/Operations and Engineering. Applicant Notices & DisclaimersFor information on benefits, equal opportunity employment, and location-specific applicant notices, click here
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the QA Compliance Specialist II in North Chicago, IL vacancy
- ...control/change plan activities, and request/collection of feedback from manufacturing sites and affiliates. The person will ensure compliance to the quality system as it pertains to Supplier Change Notifications. Responsibilities: Monitor global Supplier Change...Suggested
- A leading pharmaceutical company in North Chicago is seeking a Quality Assurance Specialist to monitor Supplier Change Notifications and ensure compliance with quality systems. The ideal candidate should have over 4 years of experience in quality assurance and a Bachelor...Suggested
$30 - $35 per hour
...Quality Assurance Compliance Specialist IIPay Range: $30/hr to $35/hrLocation: North Chicago, IL 60064Work Type: OnsiteContract Duration: 12 Months... ...an experienced Quality Assurance Compliance Specialist II to support quality and compliance activities within a large enterprise...SuggestedTemporary workCollabera
Great Lakes, IL2 days ago- Abbott is seeking a Regulatory Affairs Specialist II at our Lake Forest, IL location. This role focuses on implementing and maintaining the quality system, supporting change control, and preparing U.S. regulatory submissions for products and international affiliates. The...Suggested
$68k - $136k
...serve people in more than 160 countries. Regulatory Affairs Specialist II Working at Abbott At Abbott, you can do work that matters, grow... ..., implements, and maintains the quality policy. Ensures compliance and is able to demonstrate knowledge of site and division level...SuggestedWork experience placementWorldwide- ...Job Description Job Description Description: Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution... ...Person for NPI launches Execute placement and removal of QA Holds in warehouse management system Manage/Post supplier...Permanent employmentFull timeContract work
- ...4.Familiar with Aseptic Process 5.Combination Product The QA Senior Specialist is responsible for providing quality assurance support for... ...material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities...For contractors
$28 per hour
jobr.pro is seeking a Microbiologist I in Lincolnshire, Illinois. The role involves conducting microbiological analyses of materials under supervision, preparing necessary media and reagents, and maintaining quality standards through meticulous recordkeeping. The ideal ...Hourly pay- ...StatesCompany: BaxterPosted: 2026-08-13Baxter International Inc. seeks a Quality Associate II within the Quality organization to uphold audit quality systems and regulatory compliance. You will manage internal audits, CAPA, inspections readiness, and mentor junior staff...Worldwide
- ...QA SpecialistApex Systems is seeking a QA Specialist for an immediate 3+ month contract opportunity with one of our Fortune 500 Healthcare Clients.Duties:... ...scientific laboratory testing and evaluation to ensure the compliance and safety of the company's products.Description...Contract workImmediate start
Software Technology Inc
Waukegan, IL2 days ago - This position provides direct support to ACPRU Data Systems staff with regards to Phase 1 Clinical Research Studies conducted at the Clinical Pharmacology Research Unit (ACPRU). Responsibilities include: review source documentation and facilitate discrepancy reconciliation...Permanent employmentImmediate start
- Senior International Trade Compliance SpecialistCorporate Headquarters12575 Uline Drive, Pleasant Prairie, WI 53158Interested in the global... ...materials! As a Senior International Trade Compliance Specialist, you’ll tackle regulatory hurdles, find tariff savings and bring...Full time
- Nielsen‑Massey Vanillas is seeking a Food Safety Quality Assurance (FSQA) Technician to support production floor and laboratory on first shift in Waukegan, Illinois. You will monitor, verify, and document day‑to‑day food safety practices to ensure products meet safety regulations...Full timeDay shift
$88k - $121k
...never the same from one day to the next. As a Quality Associate II, you are unafraid of navigating through necessary internal processes... ...better product for our customers. You will independently manage compliance audit processes and serve as a knowledgeable resource for...Odd jobTemporary workWorldwideWork visaFlexible hours- A clinical research support company is seeking candidates for a position providing direct support to Clinical Pharmacology Research Unit staff with responsibilities in data management across Phase 1 Clinical Research Studies. Applicants must have a high school diploma or...Permanent employment
- ...Ajulia Executive Search is seeking a Quality Assurance Technician to support QA/QC operations by calibrating equipment, performing tests, and ensuring regulatory compliance. This role contributes to product quality and continuous improvement across the organization. You...
Ajulia Executive Search
North Chicago, IL1 day ago $16.5 - $19 per hour
.... Enforce Good Manufacturing Practices and safety policies. Provide QA coverage for assigned production lines. Demonstrate good work habits with attention to detail. Ensure compliance to quality standards, SOP's and programs are being met. Communicate all...Hourly payContract workWork experience placementWork at officeLocal areaFlexible hoursShift workNight shiftThe Visual Pak Companies
Waukegan, IL4 days ago- ...Consulting Group, LLC is seeking a Personnel Assistant II (Identity Credentialing Specialist) to provide professional customer service and administrative... ..., and maintains electronic records while ensuring compliance with organizational policies and security requirements....
- A global construction solutions company based in Gurnee, Illinois, is seeking a Plant Operator to manage various duties within a manufacturing environment. The role includes operating a forklift, conducting quality control testing, unloading raw materials, and supporting...
- ...supervisory oversight. Review raw data, protocols and research reports to assure the quality and integrity of the results as well as compliance to protocols, policies, procedures, and applicable governmental regulations; and be able to evaluate the potential risk of...Temporary work
- ...Job Description Job Description Description: The QA Senior Specialist is responsible for providing quality assurance support for the... ...material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Include...Permanent employmentFull timeContract workFor contractors
$78k - $156k
...mothers, female executives, and scientists.The OpportunityOur location in Lake County, IL currently has an opportunity for Sr IT Compliance Analyst - CAPA. Establishes and maintains productive relationships with all levels in the BTS and Divisional IT organizations and...Worldwide- ...a week in office.Job SummaryThe Principal Regulatory Affairs Specialist will support the Medical Solutions Regulatory affairs team. They... ...design inputs and design outputs.Review product labeling for compliance with global labeling regulations.Interpret and evaluate proposed...Full timeTemporary workWork experience placementWork at officeLocal areaImmediate start
- ...Network Security EngineerWe are seeking a dedicated professional to join our team to support ongoing risk, vulnerability, and compliance management activities. This role requires a blend of technical awareness, organizational coordination, and risk management responsibilities...
Artech
Deerfield, IL2 days ago $88k - $121k
...never the same from one day to the next. As a Quality Associate II, you are unafraid of navigating through necessary internal processes... ...Assess proposed changes for regulatory, product quality, and compliance impact; coordinate cross-functional review and approval....Odd jobFull timeTemporary workWork at officeWorldwideWork visaFlexible hours$88k - $121k
...never the same from one day to the next. As a Quality Associate II, you are unafraid of navigating through necessary internal processes... ...Assess proposed changes for regulatory, product quality, and compliance impact; coordinate cross-functional review and approval....Odd jobTemporary workWork at officeWorldwideWork visaFlexible hours$55.64k - $92.73k
...Compliance Officer The Compliance Officer is responsible for administering and improving all aspects of the credit union's compliance management program. This position plans and organizes the administrative, lending, deposit, operational and marketing compliance activities...Local areaALEC
Gurnee, IL5 days ago- ...via text, text 10697 to (***) ***-****. Bilingual Preferred The QA Specialist is responsible for conducting on-site client evaluations and... ...in working groups councils and committees Insurance compliance with rules and regulations Participates on committees, and special...Full timeWork at officeLocal areaFlexible hours
- Katalyst CRO in Mundelein, Illinois, is seeking a candidate to support remediation activities under FDA requirements. This role involves reviewing historical complaint files, applying current FDA definitions, and preparing MDRs when necessary. The ideal candidate will have...
- ...and US registrations for medical devices. The role involves planning registration packages, liaising with agencies, and ensuring compliance across changes and submissions. Candidates should have strong regulatory expertise and cross-functional collaboration skills. The...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QA Compliance Specialist II. Be the first to apply!
Related searches
- compliance coordinator North Chicago, IL
- regulatory specialist North Chicago, IL
- compliance associate North Chicago, IL
- risk and compliance analyst North Chicago, IL
- regulatory officer North Chicago, IL
- compliance specialist North Chicago, IL
- compliance officer North Chicago, IL
- regulatory affairs specialist North Chicago, IL
- coding compliance specialist North Chicago, IL
- healthcare compliance officer North Chicago, IL