Quality Control Specialist - B Shift

Brief Description

UNDERSTANDING

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 be integral in identifying quality issues, finding proactive solutions, and fostering a culture of quality excellence within the production team.

As a transformation leader, the QC Specialist will be responsible for identifying opportunities for quality improvement across all production processes. You will play a key role in driving quality improvements by analyzing processes, finding inefficiencies, and implementing effective solutions to enhance product consistency, safety, and overall quality. This position is crucial in leading the team to continuously enhance the quality processes, ensuring that the standards set 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 that quality is built into every step of the process. This position will be critical in promoting a culture of quality and will require strong leadership to help our teams continually grow and improve.

CORE VALUES

Our 5 Core Values are more than just words, they’re a way of life. We know that companies with a strong culture & a higher purpose perform better in the long run.

• 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:
• Ensure that all production processes are being performed according to established quality standards and regulatory requirements, including monitoring gummy and supplement production for consistency in taste, texture, potency, and ingredient distribution.
• 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 in their findings.
• 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).
• Conduct environmental swabbing and ATP testing to monitor cleanliness and food safety standards in production areas.
• Oversee line changeovers, ensuring that 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 any quality discrepancies and, if standards are not met, place product on hold until quality issues are resolved.
• Ensure Compliance with FDA and cGMP Standards
• Adhere to regulatory standards: Ensure strict compliance with FDA regulations, 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: Review and approve finished product labeling to ensure compliance with FDA guidelines, including ingredient listings, claims, and allergen information.
• Maintain food safety practices: Provide guidance on food safety protocols for manufacturing, packaging, and handling to prevent contamination and ensure product safety.
• Lead Audits and Drive Corrective Actions
• Conduct internal audits: Perform 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: Use data to identify trends or recurring quality issues early, escalating and addressing them promptly with corrective actions.
• Drive corrective and preventive actions (CAPA): Lead root cause analysis and implement CAPA programs to resolve quality deviations, working cross-functionally to monitor the effectiveness of corrective actions.
• Foster Continuous Improvement and Process Efficiency
• Identify opportunities for quality improvement: 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: Lead by example in problem-solving and encourage the team to approach challenges with creativity, always striving to improve processes and achieve better outcomes.
• Support innovation: Encourage a creative and innovative approach to improving quality, leveraging cross-departmental collaboration to implement new ideas and solutions that support the company’s long-term goals.
• Provide Training, Documentation, and Reporting
• Train and mentor teams on quality processes: Lead training efforts for Operations and other teams on new or updated quality procedures, ensuring consistency in how quality standards are applied.
• Track and report quality performance: Monitor and report key quality metrics (KPIs), proactively identifying areas of improvement and communicating progress to leadership.
• Approve and review documentation: Ensure that 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: Act as a consistent presence on the production floor, advocating for quality at every step of the process and reinforcing the importance of compliance and quality ownership across all teams.
• Lead with creativity and accountability: Empower the team by promoting a creative and accountable environment where everyone is motivated to continuously improve and maintain the highest standards of product quality.
  

Support proactive problem-solving: Use data and real-time observations to support the team in solving issues quickly, fostering a culture where quality and safety are prioritized.

WORKING RELATIONSHIP

• Reports to the Quality Control Manager.
• Communicates regularly and has a strong relationship with team members in multiple departments.
  
  

Communicates 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:
• These are not always required, but strongly preferred:
• 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, 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