Job Description

Position Type: Full-Time

Location: Alachua, FL (Onsite Monday - Friday)

Salary: $50,000 - $60,000

Reporting to: Director of Quality

The Document Control Specialist is a member of the Quality Assurance team and collaborates with all other departments. Working within the Quality Management System with a focus on documentation, ensuring that all controlled documents (Standard Operating Procedures (SOP), batch records, policies, and forms) are current, accurate, traceable, and compliant with FDA, USP, and CGMP standards.

Key Responsibilities:

• Own the full lifecycle of controlled documents: creation, review, approval, distribution, tracking archival and retirement.
• Maintain and continuously improve the document management system (DMS).
• Assists users of the document management system (DMS) in creation, review, and approval workflows across departments.
• Ensure SOPs, work instructions, batch records, and forms are formatted to align with Strive templates.
• Train staff on document control procedures and compliance requirements.
• Support internal audits, regulatory inspections, and external accreditation reviews.
• Identify and resolve documentation gaps before they become problems.
• Partner with other quality personnel, operations, pharmacy, and engineering/facility teams to keep documentation aligned with actual practice.
• Manage change controls, deviation records, and CAPAs related to documentation and the electronic document management system.
• Any other duties required as defined by management.

Role/Site Specific Requirements:

This position may also include the following:

• This role is primarily a Sedentary role. This can include exerting up to 20 pounds of force to move objects.
• Visual acuity such as: working with data & figures, viewing computer monitor, extensive reading, operating machinery, general observations of facilities, etc.
• Participation in an occupational health program which can include; medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.

Exposure to the following:

• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
• Handling, managing, disposing non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.).
• Working in laboratories & production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled.

The items described here are representative of those that must be met to successfully perform the essential functions of this job.

Qualifications:

• 2+ years of CGMP experience in document control, quality assurance, or a regulated industry (pharmaceutical, compounding, biotech, or medical device preferred).
• Familiarity with USP <795>, <797>, <800> standards and/or FDA cGMP regulations.
• Experience working in electronic quality management systems (deviations, CAPA, and change control).
• Experience working within an electronic or paper based document management system.
• Exceptional attention to detail.
• Strong organizational skills and the ability to manage multiple document workflows simultaneously.
• Clear, concise written communication.

Bonus Qualifications:

• Experience in a compounding pharmacy or 503B outsourcing facility.
• Familiarity with PCAB accreditation or ISO quality systems.
• Experience implementation/maintenance of an electronic quality management system including management of electronic batch records, forms, and protocols.
• Experience supporting FDA inspections or state pharmacy board audits.