Job Title: Quality Specialist – Product Release and Audit Compliance

Department: Quality Location: Montgomery, IL Reports To: Quality Assurance Supervisor Job Type: Full-Time

Job Summary:

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).

Key Responsibilities:
1. Product Release:
· 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.
2. Audit and Compliance:
· 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.
3. Documentation and Record Management:
· 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.
4. Quality Systems Support:
· 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.

Qualifications:
Education:
· Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, or related field) required.
Experience:
· 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.
Skills:
· 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.

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

Disclaimer:ARM GROUP is committed to fostering a diverse and inclusive workplace. We are an Equal Employment Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.We actively encourage applications from individuals with diverse backgrounds, including people with disabilities. Accommodations are available upon request for applicants participating in all aspects of the selection process.By applying for this job, you consent to allow representatives of ARM GROUP LLC to contact you regarding your candidacy. This may include communication via email, phone, text, or other means deemed appropriate by ARM GROUP LLC. Rest assured, your information will be handled confidentially and used solely for recruitment purposes.It’s important to note that ARM Group LLC does not interfere in the decision-making process regarding your selection or rejection. The ultimate decision to hire or reject your candidacy lies solely with the client organization, with whom we have an agreement to source candidates for their considerationPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. All applicants must submit to background check and drug screening.Applicants for this position must be legally authorized to work in the United States. Please be aware that this position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
Looking forward to connecting with you!
Job Type: Full-time
Pay: $55,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• Health insurance

Work Location: In perso

Please refer the Job description for details