Albanese Confectionery Group, Inc
Quality Control Specialist - Day Shift
Albanese Confectionery Group, Inc, Merrillville, Indiana, us, 46411
3 days ago Be among the first 25 applicants
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.
Brief Description 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
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 security 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 strict compliance with FDA regulations, including 21 CFR Part 111 and 21 CFR Part 117, and cGMPs for dietary supplements and confectionery products.
Monitor labeling and packaging compliance.
Maintain food safety practices.
Lead Audits and Drive Corrective Actions: Conduct internal GMP audits, identify risks, implement CAPA programs.
Foster Continuous Improvement and Process Efficiency: Identify opportunities for quality improvement, implement changes to improve consistency.
Provide Training, Documentation, and Reporting: Train and mentor teams on quality processes, track and report quality performance.
Advocate for a Culture of Quality and Compliance: Promote a culture of quality, empower team, and support proactive problem‑solving.
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
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 (scales, temperature probes), performing ATP/environmental swabbing, sample collection, label verification.
Familiarity with ERP/MES or electronic batch records systems.
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 providing real-time feedback to Operations on deviations or documentation errors.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Food and Beverage Manufacturing
Referrals increase your chances of interviewing at Albanese Confectionery Group, Inc by 2x
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Merrillville, IN .
Lake County, IN $55,000 - $65,000 3 weeks ago
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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.
Brief Description 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
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 security 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 strict compliance with FDA regulations, including 21 CFR Part 111 and 21 CFR Part 117, and cGMPs for dietary supplements and confectionery products.
Monitor labeling and packaging compliance.
Maintain food safety practices.
Lead Audits and Drive Corrective Actions: Conduct internal GMP audits, identify risks, implement CAPA programs.
Foster Continuous Improvement and Process Efficiency: Identify opportunities for quality improvement, implement changes to improve consistency.
Provide Training, Documentation, and Reporting: Train and mentor teams on quality processes, track and report quality performance.
Advocate for a Culture of Quality and Compliance: Promote a culture of quality, empower team, and support proactive problem‑solving.
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
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 (scales, temperature probes), performing ATP/environmental swabbing, sample collection, label verification.
Familiarity with ERP/MES or electronic batch records systems.
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 providing real-time feedback to Operations on deviations or documentation errors.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Food and Beverage Manufacturing
Referrals increase your chances of interviewing at Albanese Confectionery Group, Inc by 2x
Get notified about new Quality Assurance Specialist jobs in
Merrillville, IN .
Lake County, IN $55,000 - $65,000 3 weeks ago
#J-18808-Ljbffr