Quality Control / Quality Assurance Lead

INW: Innovations in Nutrition and WellnessBenicia, CA
Onsite

About The Position

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.

Requirements

  • 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
  • High School Diploma or higher degree

Nice To Haves

  • 3-5 years of GMP manufacturing experience preferred

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Benefits

  • 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
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