QA Document Compliance Specialist

Position Summary

The Quality Assurance Document Compliance Specialist is responsible for the development and revisions of SOPs, policies, and other documents. This role partners Quality Assurance, Learning and Development (L&D), and operational teams to ensure documentation is accurate, compliant, clearly written, and effectively translated into training and operational readiness.

• Assist document control with change control processes and ensure accuracy
• Help author, review, edit, maintain, and update SOPs, policies, and guidelines in collaboration with subject matter experts (SMEs)
• Provide clarity to documents, and ensure they meet quality, compliance, and regulatory standards (e.g., cGMP, internal quality standards, 21 CFR 111 and others)
• Collaborate with all departments to maximize support, help with documentation changes that will align with quality standards
• Support audit readiness by maintaining accurate and current controlled documents
• Ensure document reviews are addressed and completed in a timely manner with stakeholders
• Write and edit SOPs and other documents in a clear, learner-friendly format that supports effective training
• Create diagrams, flowcharts, and visual aids to support written content
• Provide timely notification and documentation updates to support training development, document-based learning, and rollout
• Act as a liaison between Quality, L&D, and operational teams to align expectations
• Track project progress, trend and monitor KPIs associated with SOP updates, consolidation and approvals
• Perform vertical audits of SOPs
• Perform other duties and responsibilities, as assigned and as necessary

• Duties are performed primarily in a smoke-free manufacturing environment
• We pride ourselves on maintaining a clean and organized environment, fostering a sense of pride and ownership in our space
• Our culture is rich in diversity, quality, safety, fun, and respect, creating a vibrant and inclusive atmosphere
• We are dedicated to professionalism and growth, continually striving to improve and excel in all we do

• Associates degree in a scientific, technical, or related field, or equivalent relevant industry experience required;
  Bachelor's degree preferred, with an emphasis in English, communication or technical writing
• 1-2 years of Quality Assurance or technical writing experience in a regulated manufacturing environment, including preparation and maintenance of controlled documents preferred
  
  Must possess good computer skills to be proficient in Microsoft Office
• Be able to learn, use and train on in-house computer programs (PCLe)
• Demonstrated experience reviewing, writing, and reading standard operating procedures (SOPs) with knowledge of cGMP requirements and FDA regulations, including 21 CFR Part 111
• Detail-oriented, with developed analytical and problem-solving skills
• Strong written and verbal communication skills, with ability to read, interpret and convey technical and regulatory information
• Working knowledge of quality systems and regulatory affairs within the dietary supplement, food, or pharmaceutical industry preferred
• Must be able to work overtime or on weekends as needed

• Frequent sitting
• Must be able to stand, walk, stoop, kneel, crouch, climb, balance, and reach
• Regularly lift and/or move up to 25 lbs
• Occasionally lift and/or move up to 50 lbs

Pro Caps provides :

• A competitive salary!
• Top-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program!
• Paid Time Off, Eight (8) Company Holidays
• 401(k) with Company Match - up to 4.5%
• 100% Company Life Coverage
• 100% Short Term Disability Coverage
• Gym Membership Reimbursement
• Vitamin Allowance + Discounts
• Company-Funded Health Savings Account ($1,600/year)
• Cash Reward Employee Referral Program
• Pet Insurance
• Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!