Document Control Specialist
Welcome to VVF Illinois Services, LLC! We're part of VVF Group, a world leader in manufacturing of Oleo Chemicals and Personal Care products founded in 1939. We are one of the largest contract manufacturers of personal care products in the world. Here in Montgomery, Illinois, we focus on the manufacturing and distribution of Personal Care Products - we manufacture bar soaps, deodorants, antiperspirants and gels. At VVF, it's not about the job, it's about the experience. We strive to create an exceptional environment for our employees, shaped by fair practices and excellent opportunities for career growth and a working culture that embraces diversity.
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.
Job Duties:
- 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.
Education Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry or related field
Minimum Work Requirements:
- 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)
Preferred Qualifications:
- 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
- 3–5 years of experience in Quality Assurance or Document Control in a regulated manufacturing environment, preferably in OTC, pharmaceutical, or medical device industry
- 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
Physical Requirements:
The ability to stand or walk for long periods, good vision and hearing and the physical strength and endurance to handle confrontations or emergencies.
At VVF, our people are what make the difference. Benefits for this position include medical, dental and vision insurance available on day 1 of employment. Life Insurance, Short-Term and Long-Term Disability coverages are provided and paid for by the company. We offer a company match on employee contributions into our available 401(k) retirement plan. Enjoy company paid holidays and vacation time as well as a business casual work environment.
VVF is an equal opportunity employer. We evaluate qualified applicants, without regard to race, color, religion, national origin, sex or gender, age, disability, veteran status, sexual orientation, gender identity or expression, genetic information, including the perception that a person has any of those characteristics or that the person is associated with a person who has, or is perceived to have, any of those characteristics, or any other consideration made unlawful by applicable law. VVF is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to [email protected] or call Human Resources at (630) 801-4607 and let us know the nature of your request and your contact information.
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