Albanese Confectionery Group, Inc
Quality Control Specialist - Night Shift
Albanese Confectionery Group, Inc, Merrillville, Indiana, us, 46411
Overview
Quality Control Specialist - Night Shift
at Albanese Confectionery Group, Inc. 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.
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, including 21 CFR Part 111 and 21 CFR Part 117
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, advocate for quality at every step of the process and reinforce 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
Qualifications
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 111/117
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), 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
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Food and Beverage Manufacturing
This job description contains information about the role and requirements for the QC Specialist - Night Shift at Albanese Confectionery Group, Inc.
#J-18808-Ljbffr
at Albanese Confectionery Group, Inc. 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.
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, including 21 CFR Part 111 and 21 CFR Part 117
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, advocate for quality at every step of the process and reinforce 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
Qualifications
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 111/117
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), 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
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Food and Beverage Manufacturing
This job description contains information about the role and requirements for the QC Specialist - Night Shift at Albanese Confectionery Group, Inc.
#J-18808-Ljbffr