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QA Compliance Specialist

Open 45d posting dated last week

Summary

Reviews and maintains compliance documentation for dietary supplements, including labels and batch records, ensuring adherence to cGMP and regulatory standards.

POSITION SUMMARY

The QA Compliance Specialist supports quality assurance and compliance activities, such as assisting with product documentation, label and Supplement Facts review support, batch documentation readiness, internal audit preparation, and other tasks. This position works cross-functionally with Quality Assurance, Quality Control, and across departments to help ensure quality records and compliance-related activities are accurate, complete, current, and operationally ready. The role is responsible for coordinating, tracking, reviewing for completeness, and escalating quality-related activities in accordance with company procedures, cGMP requirements, customer requirements, and applicable regulatory expectations for food and dietary supplement manufacturing.

OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

  • Manage, execute, and/or assist with review of Supplement Facts panels, labels, QA/QC specifications, product specifications, Master Manufacturing Records, batch tickets, required attachments, and related product or production documentation to ensure completeness, accuracy, alignment with approved requirements, and production readiness
  • Maintain and assist in managing the approved suppliers/vendors, supplier qualification files, supplier review records, and supplier status tracking, including follow-up on missing, expired, or updated supplier documentation
  • Assist with Amazon compliance documentation and requests, and related quality or regulatory information requests
  • Review and coordinate quarantine material, destruction lists and related quality tracking records; including holds, releases, rejections, returns, destruction activities, and pending disposition activities
  • Assist with Material Review Board activities by preparing documentation, compiling supporting records, tracking decisions, monitoring action items, and following up on assigned closure activities
  • Assist in planning, preparing, executing, documenting, and following up on internal audits in accordance with the internal audit schedule and company procedures
  • Input, maintain, and verify quality-related data in MES, ERP, PCLe, document control systems, or other electronic quality systems as assigned
  • Escalate quality, compliance, documentation, supplier, labeling, batch record, quarantine, audit, or MRB concerns to QA management as appropriate
  • Perform other duties and responsibilities as assigned

WORK ENVIRONMENT

  • Duties are performed in a smoke-free office and production environment
  • Employees may be required to enter production, warehouse, laboratory, and controlled quality areas while following company safety rules, cGMP requirements, gowning procedures, hygiene practices, and applicable quality procedures

Requirements

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS

  • High school diploma or equivalent required; associate or bachelor’s degree in science, food science, nutrition, or related field preferred
  • Minimum of 1–3 years of experience in Quality Assurance, Quality Control, Regulatory, Compliance, Document Control, or manufacturing support within a dietary supplement, food, or other FDA-regulated manufacturing environment preferred
  • Working knowledge of cGMP documentation practices, controlled records, product specifications, supplier qualification, internal audits, and quality systems preferred
  • Experience supporting label review, Supplement Facts review, product specifications, MMRs, batch records, customer compliance documentation, or supplier qualification documentation preferred
  • Familiarity with 21 CFR Part 111 dietary supplement cGMP requirements preferred
  • Must possess good computer skills, proficient in Microsoft Office, including Word, Excel, Outlook, and related business systems
  • Be able to learn and use in-house computer programs including PCLe, MES, ERP, document control, or electronic quality systems as assigned
  • Detail-oriented, with the ability to review documents for completeness, consistency, accuracy, and alignment with approved requirements
  • Strong written and verbal communication skills, with ability to read, interpret, and communicate technical and quality information
  • Must be able to organize multiple priorities, track open action items, follow up with stakeholders, escalate issues appropriately, and work independently while following established procedures and management direction
  • Must be able to work overtime or on weekends as needed

PHYSICAL REQUIREMENTS

  • Frequent sitting, standing, walking, and climbing. Able to lift up to 25 lbs.

Benefits

ProCaps Laboratories provides:

  • A starting pay of $28.37 an hour! DOE
  • Top-Tier Medical, Dental & Vision Coverage – $0 cost when you qualify for our Wellness Program
  • Generous Paid Time Off – includes 8 paid company holidays
  • 401(k) with Company Match – up to 4.5%
  • 100% Company-Paid Life Insurance
  • 100% Company-Paid Short-Term Disability Insurance
  • Gym Membership Reimbursement
  • Monthly Vitamin Allowance + Employee Discounts on Products
  • Company-Funded Health Savings Account (HSA) – $1,600 annually
  • Cash Bonuses Through Employee Referral Program
  • Optional Pet Insurance Available
  • 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!

What this application asks

workable

First name, Last name, Email, Phone, Address, Resume, Experience, Education, How would you like us to get in touch?, Proficiency in speaking, reading, and writing in English is required for this position. This requirement is necessary for effective communication, cGMP & Safety protocols, and compliance with company policies.Do you meet this requirement?, Which computer programs or software are you familiar with? (Examples: Microsoft Excel, Word, Outlook, data entry systems, inventory software, timeclock or scheduling tools). Please list any programs you’ve used:, Please include your preferred shift or time of day, and note any limitations we should be aware of:, What are your salary expectations for this role?, What do you know about ProCaps Laboratories, and what excites you most about the opportunity to join our team?, ProCaps Laboratories operates in an environment where certain food allergens may be present including but are not limited to: MILK, EGGS, FISH, CRUSTACEAN SHELLFISH, TREE NUTS, PEANUTS, WHEAT, SOYBEANS, and SESAME. Many of our roles may involve exposure to one or more of these substances. Due to the nature of our manufacturing environment, complete elimination of allergen exposure CANNOT be guaranteed. Are you able to perform the essential functions of this job, with or without reasonable accommodation?, Have you previously worked at ProCaps Laboratories as a Regular Employee, a Consultant, or through a Staffing Agency? If yes, please state dates of employment, position held, and name of Staffing Agency (if applicable):, Do you have any friend(s) and/or relative(s) currently working at ProCaps Laboratories? If yes, please provide the name(s)., Are you referred by a current ProCaps employee? Is YES, please list the employee name(s).

  • This position requires working in a fast-paced, repetitive, and physically demanding environment. It frequently involves WALKING, bending, kneeling, crouching, balancing, reaching and standing for extended period. Employees are regularly required to lift and/or move up to 50 lbs., and may need to push or pull up to 300 lbs. using proper equipment. Are you comfortable with these physical demands and able to perform the essential functions of this job, with or without reasonable accommodation? (Yes/No – If NO, please explain.)
  • This role prefers a minimum of 3 years of work experience in a manufacturing, cGMP-regulated, or food related quality environment. Please briefly describe your relevant experience. written answer
  • Please describe your experience following Standard Operating Procedures (SOPs) or Good Manufacturing Practices (GMP)? written answer
  • Are you at least 18 years of age or older? yes / no
  • Do you have a high school diploma or GED? (Please note: Education credentials will be verified with the issuing school or institution.) yes / no
  • ProCaps Labs participates in E-Verify, a system used to verify employment eligibility. If hired, will you be able to provide valid/unexpired documents to complete the E-Verify process? yes / no
  • Please select the option that best describes your current work authorization status in the United States. Note: This information is collected only to assess employment eligibility. ProCaps Laboratories does not discriminate on the basis of citizenship, immigration status, or national origin. choose one
  • Location & Commute: Please select the option that best describes your current situation. This role prefers someone who is willing to work ONSITE. choose any
  • PLEASE READ THE FOLLOWING CAREFULLY : I certify that all information provided in this application is true and complete to the best of my knowledge. I understand that any false statement, misrepresentation, or omission may result in disqualification from consideration or, if employed, immediate termination. I understand that submitting this application does not guarantee employment and does not create a contract or promise of future employment with ProCaps Laboratories. I also understand that, if offered employment, my position will be subject to the company’s policies, including background checks, eligibility verification, and compliance with all job-related requirements. Do you acknowledge and agree to this statement? ☐ Yes ☐ No yes / no