Job Title: Quality Specialist – Document Control and Records Management
Department: Quality
Reports To: Quality Assurance Supervisor
Location: Montgomery, IL
Payrate: 55k-60k
Job Type: Full-Time
Position Summary:
The Quality Specialist – Document Control and Records Management is responsible for the creation, revision, issuance, and archiving of controlled documents to ensure compliance with cGMP, FDA regulations, customer requirements and company policies. This role is critical in supporting the document lifecycle and maintaining the integrity of quality records associated with the manufacture of OTC drug products and cosmetic products.
Key Responsibilities:
- Maintain and manage the Document Control System (physical and electronic) for all controlled documents (e.g., SOPs, Batch Records, Forms, Specifications, QMS records).
- Review and process document change requests and change control documentation in accordance with internal procedures.
- Ensure timely issuance, revision, approval, and obsolescence of documents per applicable SOPs.
- Coordinate with cross-functional departments (Quality, Production, Engineering, Warehousing, R&D etc.) to ensure document compliance and alignment with current practices and regulatory requirements.
- Maintain secure and traceable storage of quality records, including batch production records, lab notebooks, and validation reports.
- Support audits and regulatory inspections by retrieving, reviewing, and organizing required documents and records.
- Track and report metrics related to document turnaround time, on-time training, and outstanding records.
- Assist in the implementation and maintenance of electronic document management systems (EDMS) as applicable.
- Conduct periodic audits of the document control system to ensure accuracy, completeness, and compliance.
- Provide training to employees on document control procedures and document management system use.
- Support continuous improvement initiatives in documentation practices and records management.
Qualifications:
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field.
- Experience: 3–5 years of experience in Quality Assurance or Document Control in a regulated manufacturing environment, preferably in OTC, pharmaceutical, or medical device industry.
- Knowledge:
- Strong understanding of cGMP, 21 CFR Part 211, Part 11, MoCRA, FDA requirements and ISO 22716, ISO 9001, ISO 17025 standards.
- Familiarity with ICH, USP, and other regulatory standards applicable to OTC drugs and cosmetics.
- Experience with electronic document management systems (e.g., MasterControl, Veeva, QUMAS).
- Skills:
- Strong attention to detail and organizational skills.
- Proficient in MS Office (Word, Excel, Outlook, PowerPoint).
- Excellent written and verbal communication skills.
- Ability to manage multiple tasks and deadlines efficiently.
Preferred Skills:
- Experience with Lean or Six Sigma documentation improvement initiatives.
- Prior participation in FDA or other regulatory inspections.
- Knowledge of records retention policies and archival systems.
Work Environment:
- Office-based with access to manufacturing and laboratory areas.
- May require handling of confidential or sensitive documentation.
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 consideration
Please 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.