Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands.
Summary: The Gummy QA Technician ensures the safety, quality, and compliance of vitamin and mineral supplement gummies, working closely with the production team to monitor manufacturing processes and perform quality checks. This role requires hands-on involvement on the production floor, confirming critical control points (CCPs), reviewing Production Batch Records (PBRs), and addressing non-conformance through NCRs, deviations, and CAPAs. This role will also be asked to assist with production activities when needed and will play a key part in upholding standards in a fast-paced, SQF-certified, and NSF GMP-certified environment.
Essential Duties and Responsibilities:
- Process Monitoring & In-Process Testing:
- Per compliance to cGMP, adhere, monitor, and verify adherence to standard operating procedures (SOPs), SQF Policies and training within the company but not limited to Manufacturing, Quality, Warehouse, and Maintenance operations.
- Aseptic sampling of Raw Materials received to submit to QC for testing.
- Ensure that all quality systems are compliant with current SQF Code requirements, including Modules 2 & 17 for food safety fundamentals and dietary supplement manufacturing.
- Execute appropriate responsibilities established for Quality Assurance as dictated by the established SOPs and SQF Policies
- Monitor and conduct in-line inspections at key production stages, including raw material verification, gummy mold filling, and final packaging.
- Inspect and verify all clean-in-place (CIP) and sanitize-in-place (SIP) processes for gummy production.
- Oversee quality parameters such as moisture content, pH, Brix levels, and net weight accuracy to ensure all products meet defined specifications.
- Perform sensory evaluations (taste, texture, appearance) to verify that fmished gummies meet established quality standards.
- Ensure calibration records for critical testing equipment such as refractometers, pH meters, scales, and all other production equipment are up-to-date and meet applicable calibration standards.
- Critical Control Point (CCP) Management:
- Observe and confirm that production staff correctly perform CCP checks, including metal detection, temperature monitoring, and allergen control procedures.
- Sign off on CCP records and ensure all documentation is properly completed and verified.
- Production Record Review:
- Review Production Batch Records (PBRs) for accuracy and completeness. Subsequently, release/reject finished packaged products.
- Ensure proper documentation of quality checks, corrective actions, and production parameters.
- Inspect Acceptable Quality Level retains (AQL) for acceptance/rejection and submit the samples of acceptable AQL retains to Quality Control for laboratory testing.
- Participate in mock recall drills and ensure traceability of gummy products from raw materials to fmal consumer units through Lot tracing and Production Batch Record review.
- Non-Conformance & Corrective Actions:
- Identify, document, and address any non-conformances or deviations from established processes by initiating NCRs and deviations.
- Assist in root cause analysis and implementation of Corrective and Preventive Actions (CAPAs).
- Cross-Department Collaboration:
- Work closely with production, sanitation, maintenance, and R&D teams to ensure smooth production while maintaining quality and safety standards.
- Assist production when needed, including line clearance, equipment setup, and product inspections to minimize downtime.
- Compliance & Audits:
- Ensure adherence to SQF, NSF GMP, and NSF GMP for Sport standards.
- Prepare for internal and external audits by ensuring quality records are properly maintained and accessible.
- Participate in annual refresher training on SQF and GMP requirements.
- Audit and maintain pest control logs and ensure external and internal pest management programs align with established SOPs, SQF Policies and regulatory requirements.
- HACCP & Food Safety:
- Maintain the facility's HACCP plan, ensuring CCPs are monitored and controlled.
- Conduct regular environmental monitoring, including swab tests for allergens and microbial contaminants on production equipment and surfaces.
- Assist in mock recall drills, ensuring traceability of ingredients and finished products.
- Training & Continuous Improvement:
- Provide training to production staff on GMPs, allergen control, and hygienic practices.
- Participate in continuous improvement efforts to enhance production efficiency while maintaining high product quality.
Required Qualifications/Education:
- High school diploma or equivalent (Associate's or Bachelor's degree in Food Science, Microbiology, or related field is a plus).
- 2+ years of experience in quality assurance, preferred but not required.
- Experience in food or dietary supplement manufacturing with gummy products, preferred.
- Familiarity with SQF, HACCP, and GMP requirements.
- Strong attention to detail and proficiency with quality testing equipment (e.g., pH meters, moisture analyzers, refractometers).
- Ability to perform root cause analysis and implement CAPAs.
Preferred Qualifications:
- HACCP or SQF Practitioner certification.
- Hands-on experience with gummy production processes (e.g., gelatin or pectin-based formulas).
- Experience with ERP systems for quality and traceability.
Skills /Experience:
- Working knowledge of cGMP's and FDA regulations
- General proficiency in using Microsoft Word, Excel, Outlook, and Powerpoint
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel; reach, climb, balance, stoop, kneel, crouch, talk and hear.
Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.
