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Albanese Confectionery Group, Inc · 2 weeks ago

Quality Control Specialist - Night Shift

Merrillville, IN

Full-time

Onsite

Entry, Mid Level

2+ years exp

Albanese Confectionery Group, Inc is seeking a Quality Control (QC) Specialist who will ensure that dietary supplements and confectionery products meet the highest quality standards. This role involves monitoring production processes, conducting audits, and fostering a culture of quality excellence within the production team.

Food Production

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

Qualification

CGMPsFDA regulationsQuality Control experienceInternal AuditsRoot Cause AnalysisCAPA investigationsFood Safety programsProactive mindsetDetail-orientedCommunicationCollaborative