Position Summary
The Document Control Specialist is responsible for the creation, revision, issuance, distribution, and archival of all controlled quality documents at UNIPACK LLC, an OTC pharmaceutical manufacturing facility operating under 21 CFR Parts 210/211 (and 21 CFR Part 820 where applicable to Class II device operations). The company currently maintains a paper-based Quality Management System (QMS) and is transitioning to an electronic QMS (eQMS). This role is central to that transition: the incumbent will maintain day-to-day paper-based document control operations while simultaneously supporting SOP restructuring, data migration, and validation activities needed to go live on the electronic system. The ideal candidate is detail-oriented, comfortable working within GMP document conventions, and able to manage competing priorities in a fast-paced, remediation-focused quality environment.
Key Responsibilities
- Maintain the master document list and current revision status for all controlled documents.
- Issue, distribute, and track controlled copies of SOPs, forms, and logbook pages.
- Retrieve obsolete copies so only current revisions stay in use at the point of use.
- Assign and track document numbers per the site numbering convention.
- Manage the document archive and record retention per the retention SOP.
- Draft, format, and route new and revised SOPs, work instructions, and forms.
- Manage the SOP periodic-review cycle and follow up on overdue reviews.
- Coordinate review/approval routing and keep revision history traceable.
- Issue and control all site logbooks, and review them for completeness before archiving.
- Generate and control blank forms to prevent uncontrolled duplication.
- Support change control, CAPA, and deviation documentation, and reissue affected documents promptly.
- Support the paper-to-eQMS transition, including migration, CSV documentation, and end-user training.
- Maintain GMP training records tied to document issuance.
- Keep document-control records audit- and inspection-ready.
QualificationsEducation
- High school diploma or equivalent required; Associate's or Bachelor's degree preferred (Life Sciences, Quality, Business Administration, or related field).
Experience
- 1–3+ years of document control, quality systems, or GMP administrative experience in a pharmaceutical, medical device, food, or other regulated manufacturing environment preferred.
- Prior exposure to an eQMS platform (e.g., Arena, MasterControl, Veeva, TrackWise) is a strong plus, but not required.
Skills & Attributes
- Working knowledge of GMP documentation practices (21 CFR 210/211) and good documentation practice (GDP) conventions.
- High attention to detail and comfort with repetitive, precision-driven administrative work (numbering, filing, reconciliation).
- Strong organizational skills; able to manage multiple concurrent document workflows and deadlines.
- Proficient in Microsoft Word, Excel, and Outlook; able to learn new eQMS software quickly.
- Clear written communication skills for drafting and editing SOPs.
- Trustworthy and discreet with confidential company and compliance records.
Work Environment / Physical Requirements
- Primarily office/document-room based, with regular walkthroughs of production, warehouse, and QC areas to issue/retrieve controlled documents and logbooks.
- Occasional lifting of document boxes/binders (up to ~25 lbs) for archival purposes.
- May require PPE (safety glasses, lab coat, hairnet) when entering production areas.
Pay: $45,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Do you live within a 1 hour commute?
- Do you now or in the future need visa sponsorship?
- Is your resume current?
Work Location: In person
