Document Control Specialist

Company Overview:

Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approach—one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers.

Compounding gives us the tools to do that. Every formulation we prepare is built to the specific needs of a specific person, and every interaction we have is guided by that same commitment to personalized care.

We're growing, and we're looking for people who share that conviction. If you're ready to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you.

Mission:

Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like.

Position Type: Full-Time

Location: Alachua, FL (Onsite Monday - Friday)

Salary: $50,000 - $60,000

Reporting to: Director of Quality

Position Overview:

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.

Work Environment: This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities.

Join Us in Making an Impact:

At Strive, the work is real and the impact is direct. Every role here contributes to a patient experience that's more personal, more attentive, and more human than what most people have come to expect from a pharmacy. Apply today and help us raise the bar.

Benefits/ Perks:

Strive Pharmacy offers a comprehensive benefits package, including:

• Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
• Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
• Paid time off
• Sick time
• FSA and HSA options
• Parental leave
• 401(k) with employer matching
• Life insurance
• Vision and dental insurance
• Veterinary insurance

Culture:

Culture isn't an afterthought at Strive. It's something we actively build. At our Gilbert, Arizona location, that looks like Food Truck Fridays and Casual Fridays. Company-wide, we also celebrate throughout the year with holiday potlucks and seasonal gatherings. We're committed to supporting the personal and professional growth of every employee, inside and outside the workplace. 

EEO:

Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.

Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.