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.
Other Essential Job Duties And Responsibilities
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
WORK ENVIRONMENT
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
Minimum Job Qualifications
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 preferredMust 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
Physical Requirements
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
Benefits ProCaps 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!
#J-18808-Ljbffr
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.
Other Essential Job Duties And Responsibilities
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
WORK ENVIRONMENT
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
Minimum Job Qualifications
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 preferredMust 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
Physical Requirements
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
Benefits ProCaps 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!
#J-18808-Ljbffr