Quality Specialist

vvf intervest, llc • Montgomery, IL

121d • Hybrid

About The Position

The Quality Specialist – Product Release and Audit Compliance is responsible for ensuring that all OTC drug products and Cosmetic products meet its quality and regulatory requirements prior to release. This role also ensures the site’s compliance with internal policies and current Good Manufacturing Practices (cGMP) as outlined by FDA 21 CFR Parts 210 and 211. The incumbent supports internal and external audits, performs batch record reviews, and drives continuous improvement within the quality management system (QMS).

Requirements

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, or related field) required.
• 3 – 5 years of experience in a GMP-regulated environment, preferably in OTC pharmaceutical manufacturing.
• Direct experience with product release and audit/inspection support is required.
• Familiarity with FDA regulations (21 CFR 210/211), USP monographs, ICH guidelines, MoCRA, ISO 22716, ISO 9001 etc.
• Strong attention to detail and critical thinking.
• Proficient in documentation review, deviation handling, and CAPA management.
• Excellent communication and organizational skills.
• Ability to work independently and manage multiple priorities.
• Authorize to work in the United States

Nice To Haves

• Experience with quality systems (e.g., TrackWise, MasterControl) is a plus.

Responsibilities

• Perform detailed review of executed batch records for completeness, accuracy, and cGMP compliance.
• Review laboratory data (e.g., COAs, analytical results, stability data) and ensure all specifications are met before product release.
• Verify label reconciliation and packaging compliance.
• Collaborate with cross-functional teams (QC, Production, Engineering, Warehouse) to resolve batch-related issues.
• Ensure timely and compliant release of products for shipment to customers.
• Prepare for, support, and respond to internal audits, third-party audits, and FDA inspections.
• Maintain audit readiness across the manufacturing facility by conducting internal self-inspections.
• Coordinate and track CAPAs, audit findings, and effectiveness checks.
• Ensure documentation practices align with ALCOA+ principles.
• Review and approve SOPs, change controls, deviations, and other GMP-related documentation.
• Ensure records are properly archived and easily retrievable for audits and inspections.
• Support electronic and paper-based document control systems.
• Participate in risk assessments, deviation investigations, and root cause analyses (RCA).
• Monitor quality metrics and trends related to product release and compliance.
• Promote continuous improvement initiatives within the QA department and broader operations.

Benefits

• medical insurance available on day 1 of employment
• dental insurance available on day 1 of employment
• vision insurance available on day 1 of employment
• Life Insurance provided and paid for by the company
• Short-Term Disability coverages provided and paid for by the company
• Long-Term Disability coverages provided and paid for by the company
• company match on employee contributions into our available 401(k) retirement plan
• company paid holidays
• vacation time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level