QA Compliance Specialist

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

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.

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!