Quality Assurance Assistant

Job Summary

ProTab Laboratories is seeking a detail-oriented and organized Quality Assurance Assistant to support daily quality assurance and quality control activities in our dietary supplement manufacturing and packaging operations. This position helps ensure that products are manufactured, packaged, labeled, documented, and released in accordance with applicable FDA regulations, current Good Manufacturing Practices (cGMP), company procedures, and customer requirements.

The Quality Assurance Assistant will maintain accurate quality records, assist with inspections and audits, support document control, and work closely with Production, Packaging, Warehouse, and other departments to maintain product quality, compliance, and food safety.

Essential Duties and Responsibilities

1. Quality Documentation and Recordkeeping

• Assist with reviewing manufacturing, packaging, and batch production records for completeness, accuracy, and compliance with established procedures.
• Maintain and organize quality records, forms, logs, specifications, and controlled documents.
• Assist with document control, including document revisions, distribution, and archiving.
• Verify that required signatures, dates, reconciliation records, and supporting documentation are completed.
• Identify missing information or documentation discrepancies and communicate them to the appropriate personnel.

2. In-Process and Finished Product Inspections

• Perform or assist with in-process inspections of dietary supplement tablets, capsules, powders, and packaged products.
• Verify product identification, lot numbers, expiration dates, labels, packaging components, and other applicable specifications.
• Assist with line clearance and packaging inspections to prevent product mix-ups, labeling errors, and cross-contamination.
• Document inspection results and report deviations or nonconformances to Quality leadership.
• Assist with product and material sampling according to established procedures.

3. Label and Packaging Component Control

• Assist with receiving, verifying, organizing, and maintaining records for labels and other packaging components.
• Verify that labels and packaging materials are approved and released before use.
• Maintain label release stickers, identification tags, specifications, and inventory logs as required.
• Help ensure that obsolete, rejected, or unreleased materials are properly identified and controlled.

4. GMP and Regulatory Compliance

• Support compliance with applicable FDA dietary supplement regulations, including 21 CFR Part 111, and applicable requirements under 21 CFR Part 117.
• Assist with routine GMP inspections of manufacturing, packaging, and warehouse areas.
• Monitor compliance with hygiene, gowning, sanitation, housekeeping, and other applicable GMP requirements.
• Report observed GMP deficiencies and assist with follow-up actions.
• Help maintain inspection readiness for FDA, NSF, customer, and other third-party audits.

5. Nonconformance and Corrective Actions

• Assist in documenting deviations, nonconformances, product complaints, and other quality issues.
• Support investigations and corrective and preventive action (CAPA) activities by collecting records and supporting information.
• Follow up on assigned action items and maintain accurate documentation.
• Escalate potential product quality, safety, or compliance concerns promptly.

6. Laboratory and Quality Control Support

• Assist with sample collection, sample identification, and submission of samples to internal or external laboratories.
• Maintain sample logs, testing records, certificates of analysis, and other supporting documentation.
• Assist with tracking laboratory results and verifying that required results and documents are available for Quality review.
• Support retention sample management and other quality control activities as assigned.

7. Training and Cross-Functional Support

• Assist with maintaining employee GMP training records and training documentation.
• Support Quality initiatives and continuous improvement projects.
• Communicate effectively with Production, Packaging, Warehouse, Purchasing, and other departments to resolve routine quality documentation issues.
• Perform other quality-related duties as assigned by Quality leadership.

Qualifications

Education and Experience

• Associate degree or coursework in food science, biology, chemistry, quality assurance, or a related field.
• Previous experience in quality assurance, quality control, food manufacturing, dietary supplement manufacturing, or pharmaceutical manufacturing is preferred.
• Familiarity with FDA cGMP requirements, particularly 21 CFR Part 111, is a plus.
• Experience with manufacturing records, document control, inspections, or laboratory documentation is desirable.

Skills and Competencies

• Strong attention to detail and accuracy.
• Good organizational, recordkeeping, and time-management skills.
• Basic computer skills, including Microsoft Word and Excel.
• Ability to read, understand, and follow SOPs, work instructions, and specifications.
• Good written and verbal communication skills.
• Ability to identify discrepancies and escalate concerns appropriately.
• Ability to work independently while collaborating effectively with a team.
• Willingness to learn regulatory requirements and company quality systems.

Physical and Work Environment Requirements

• Ability to work in manufacturing, packaging, warehouse, and laboratory-adjacent environments as required.
• Ability to stand, walk, and move throughout production areas for inspections.
• Ability to wear required protective clothing and follow facility hygiene and gowning requirements.
• Ability to lift and move samples, records, and small materials within company safety guidelines.

Performance Expectations

Successful performance in this role includes:

• Accurate, complete, and timely quality documentation.
• Consistent compliance with established SOPs and GMP requirements.
• Timely identification and communication of quality issues.
• Proper control and traceability of labels, packaging components, samples, and records.
• Effective support of internal inspections, external audits, and continuous improvement activities.

Pay: $23.00 - $27.00 per hour

Expected hours: No more than 40.0 per week

Work Location: In person