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Quality Control / Quality Assurance Lead
- United States
- United States
Über
The Quality Control / Quality Assurance Lead plays a critical role in inspection oversight, sampling verification, in-process quality control, sanitation and environmental monitoring, label control, documentation review, and deviation escalation. This position also supports investigations, CAPA activities, and continuous improvement initiatives to ensure product quality, regulatory compliance, and audit readiness. Essential Functions: Incoming Materials & Sampling:
Oversee and support inspection of incoming components upon receipt; ensure timely identification, documentation, and escalation of non-conforming conditions (e.g., damage, infestation, food safety risks). Review and verify sampling of raw materials (including expired or re-evaluation materials) to ensure compliance with established procedures and regulatory expectations. Provide guidance to team members on proper inspection and sampling techniques. Environmental & Sanitation Monitoring:
Lead execution and effectiveness of the environmental monitoring program within the facility. Review and verify routine swabbing activities during and after sanitation to ensure cleaning effectiveness. Oversee allergen cleanout verification during changeovers and ensure compliance with allergen control and cross-contact prevention requirements. Escalate adverse trends and drive follow-up actions as needed. In-Process Quality & Line Clearance:
Oversee in-line inspections to ensure correct components (raw materials, packaging, labels) are used during manufacturing and packaging operations. Verify that finished products meet approved specifications prior to release. Ensure proper line clearance and equipment cleanliness prior to start-up and between production runs. Provide real-time decision-making support to Production on quality-related issues. Label Control & Documentation:
Oversee label issuance to production lines in accordance with label control procedures. Review label reconciliation and ensure accurate return ("label go-back") of unused labels. Ensure compliance with documentation requirements and maintain audit readiness. Food Safety & Facility Compliance:
Lead daily food defense and facility security inspections; ensure completion and effectiveness. Drive compliance with cGMPs, food safety plans, and internal procedures across operations. Act as a point of contact during audits and inspections, supporting QA management. Leadership & Additional Responsibilities:
Provide day-to-day direction, coaching, and support to QA team members; ensure proper execution of responsibilities. Review and approve documentation (inspections, sampling, test results) in accordance with Good Documentation Practices (GDP). Lead initial investigations for deviations and non-conformances; ensure timely escalation and follow-up. Identify gaps, trends, and improvement opportunities; support CAPA and continuous improvement initiatives. Collaborate cross-functionally with Production, Warehouse, and Sanitation teams to resolve issues and maintain compliance. Support training of new and existing employees on QA procedures and expectations. Pay Range: $25.00 - $29.00 per hour Shift Hours: 9:00am - 5:30pm, M-F Position Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knowledge/Skills: Strong organizational skills Understanding the different means to identify raw materials and packaging components Working knowledge of 21 CFR Part 111 and 21 CFR Part 117 Understanding of cGMPs, HACCP, and allergen control programs Strong attention to detail and organizational skills Ability to follow SOPs and accurately complete documentation Effective communication and cross-functional collaboration skills. Excellent analytical skills coupled with strong problem-solving skills, executing in a collaborative manner Position requires interfacing with several departments Self-motivated and goal-oriented Able to multi-task Able to occasionally lift to 50 pounds Able to work as part of a team Available to work overtime, various shifts, weekends, and holidays as production demands Education/Experience: High School Diploma or higher degree 3-5 years of GMP manufacturing experience preferred Financial Responsibilities: N/A Reporting Relationships: Quality Control and Quality Assurance Lead – Reports to the Quality Laboratory Manager We offer Generous benefits including: Medical Insurance Vision Insurance Dental Insurance Company paid Life Insurance for the employee, their spouse and eligible children Company paid AD&D and LTD Insurance Voluntary Life and AD&D Insurance Paid Time Off and Paid Holidays 401K with company match Qualifications
Experience
Required
Resume Required Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Sprachkenntnisse
- English
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