Quality Control Specialist - A Shift

About the Role

We are seeking a Quality Control (QC) Specialist who is a dynamic thinker and proactive leader, committed to ensuring that our dietary supplements and confectionery products meet the highest quality standards and comply with regulatory requirements, including 21 CFR Part 111, 21 CFR Part 117, and cGMP. This role goes beyond traditional inspection, focusing on process verification, empowering Operations, and driving continuous improvement. You will identify quality issues, find proactive solutions, and foster a culture of quality excellence within the production team.

As a transformation leader, the QC Specialist will identify opportunities for quality improvement across all production processes. You will analyze processes, find inefficiencies, and implement effective solutions to enhance product consistency, safety, and overall quality. This position is crucial in leading the team to continuously enhance quality processes, ensuring standards for dietary supplements and confectionery products are always met or exceeded.

The QC Specialist will serve as a key advocate for compliance and food safety on the production floor, ensuring quality is built into every step of the process. This role requires strong leadership to help teams continually grow and improve.

Core Values

• Own It
• Love People
• Act for the Greater Good
• Find a Way
• Hustle and Refuse to Settle

Responsibilities

• Provide Quality Oversight and Process Verification
  • Monitor in-process production and finished products to ensure compliance with established quality standards and regulatory requirements, including consistency in taste, texture, potency, and ingredient distribution for gummy and supplement production.
  • Conduct routine checks and verifications to ensure compliance with cGMP, FDA regulations, and company procedures throughout the production process.
  • Collaborate with Operations to verify in-process inspections performed by the production team, ensuring accuracy and consistency.
  • Conduct sampling and laboratory testing per established sampling plans to verify product quality at key stages in production (e.g., during batching, after blending, and before packaging).
  • Perform environmental swabbing and ATP testing to monitor cleanliness and food safety standards in production areas.
  • Oversee line changeovers, ensuring cleaning protocols are followed, and line clearances and startup verifications are completed before production begins.
  • Approve and review finished product labeling for compliance with FDA regulations and internal quality standards.
  • Work with the Quality Assurance team to resolve quality-related issues immediately and effectively, escalating when necessary.
  • Evaluate products for quality discrepancies and place product on hold if standards are not met until issues are resolved.
• Ensure Compliance with FDA and cGMP Standards
  • Adhere to regulatory standards, including 21 CFR Part 111 (dietary supplements) and 21 CFR Part 117 (food safety), as well as cGMPs for dietary supplements and confectionery products.
  • Monitor labeling and packaging compliance to ensure adherence to FDA guidelines, including ingredient listings, claims, and allergen information.
  • Maintain food safety practices by providing guidance on manufacturing, packaging, and handling protocols to prevent contamination and ensure product safety.
• Lead Audits and Drive Corrective Actions
  • Conduct internal GMP audits to assess compliance, identify risks, and ensure quality practices are consistently followed in all areas of production.
  • Proactively identify and address quality issues using data to spot trends or recurring problems, escalating and resolving them promptly with corrective actions.
  • Lead root cause analysis and implement Corrective and Preventive Actions (CAPA) programs to resolve quality deviations, working cross-functionally to monitor effectiveness.
• Foster Continuous Improvement and Process Efficiency
  • Regularly assess production processes to identify areas where quality can be enhanced, implementing changes that improve consistency, reduce variability, and increase overall product quality.
  • Champion a "nothing is impossible" mindset by leading problem-solving efforts and encouraging the team to approach challenges with creativity.
  • Support innovation by leveraging cross-departmental collaboration to implement new ideas and solutions that align with the company’s long-term goals.
• Provide Training, Documentation, and Reporting
  • Train and mentor Operations and other teams on new or updated quality procedures to ensure consistency in applying quality standards.
  • Track and report key quality metrics (KPIs), proactively identifying areas of improvement and communicating progress to leadership.
  • Ensure manufacturing records are accurately completed in compliance with Good Documentation Practices (GDP), reviewing batch records, deviations, and inspections in real-time.
• Advocate for a Culture of Quality and Compliance
  • Promote a culture of quality by acting as a consistent presence on the production floor, advocating for quality at every step of the process.
  • Lead with creativity and accountability, empowering the team to continuously improve and maintain the highest standards of product quality.
  • Support proactive problem-solving using data and real-time observations to help the team resolve issues quickly, prioritizing quality and safety.

Working Relationship

Reports to the Quality Control Manager. Communicates regularly with team members across multiple departments and meets periodically with other departmental leaders.

Qualifications

• Required:
  • Bachelor of Science or commensurate experience.
  • Minimum of 2 years of experience in a QC or QA role in food and/or dietary supplement manufacturing.
  • Experience performing in-process checks, sampling, batch record review, or environmental monitoring.
• Preferred:
  • Experience in a facility regulated under 21 CFR Part 111 (dietary supplements) and/or Part 117 (food safety).
  • Familiarity with GMPs, FDA audits, and food safety programs (e.g., HACCP, Preventive Controls).
  • Prior involvement in internal audits, root cause analysis, and CAPA investigations.
  • Experience training or coaching Operations on quality procedures.

Preferred Certifications

• PCQI (Preventive Controls Qualified Individual) – particularly if dealing with 21 CFR Part 117.
• HACCP Certification.
• GMP or cGMP training.
• Internal Auditor Certification (e.g., ISO, SQF, or NSF).
• Food Safety or Quality Technician certification from ASQ or similar.

Skills & Competencies

• Strong Knowledge of:
  • cGMPs, FDA regulations, and standard quality procedures.
  • Quality documentation, deviation handling, and batch record review.
• Technical Skills:
  • Using quality inspection tools (e.g., scales, temperature probes).
  • Performing ATP/environmental swabbing, sample collection, and label verification.
  • Familiarity with ERP/MES or electronic batch records systems.
• Soft Skills:
  • Detail-oriented and highly organized.
  • Strong communication and interpersonal skills.
  • Ability to work independently while collaborating across departments.
  • Proactive, problem-solving mindset and willingness to lead continuous improvement.
  • Comfortable giving real-time feedback to Operations on deviations or documentation errors.