About The Position

The Manufacturing Quality Lead I coordinates quality inspection activities on the assigned shift and supports manufacturing quality processes. The role conducts inspections and investigations into customer complaints, non-conformances, and deviations; audits packaging and manufacturing lines for GMP and SOP compliance; and coordinates employee training. The Lead works with Operations, Manufacturing Support, Packaging, and Processing personnel to address quality issues, troubleshoot production problems, and recommend corrective actions to protect product quality. The role also supports MQ Supervisors with continuous improvement, safety, and operational goals. It delegates daily assignments to MQ Inspectors, helps develop and mentor team members, tracks the completion of deviations and holds, supports rework coordination, contributes to departmental metrics, and reviews documentation and procedures for completeness and compliance. The position works in manufacturing facilities and may handle ingredients, product, equipment, and tools while following safety, GMP, and food-safety requirements.

Requirements

  • High school diploma or equivalent and at least five years of quality-related experience, or an equivalent combination of experience and education.
  • Experience in quality processes, inspection, and a GMP environment.
  • Comprehensive knowledge of work centers within the area of responsibility and ability to work in trained MQ Inspection areas as needed.
  • Strong technical writing skills, including writing quality sections of quality nonconformances.
  • Food-safety and regulatory knowledge.
  • Strong problem-solving and critical-thinking skills, including the ability to investigate issues, determine root cause, document effective corrective actions, make decisions, and independently close investigations.
  • Excellent communication, listening, and team-building skills; ability to motivate and lead staff.
  • Effective time-management skills and ability to prioritize multiple tasks in a fast-paced environment with urgency and flexibility.
  • Leadership, training, and coaching skills to develop and mentor team members, train employees on current and new procedures, use KPIs for data-driven decisions, and support continuous improvement.
  • Ability to collaborate effectively with Production and maintain personable, welcoming interactions with employees and cross-functional teams.
  • Ability to handle conflict compassionately and demonstrate responsible, ethical, honest conduct while maintaining strict confidentiality.
  • Ability to read and interpret product specifications, departmental instructions, and procedure manuals; write emails and complete documentation accurately and truthfully.
  • Ability to apply fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.
  • Ability to compare results with specifications, interpret varied instructions, and investigate situations to determine root causes.
  • Excellent computer skills with Microsoft Word and Excel.
  • Ability to work a flexible schedule, including off shifts and weekends, and travel to other facilities.
  • Ability to meet the physical demands of the role, including standing and walking throughout the facility, using stairs, bending and squatting, handling and inspecting products, and performing the specified lifting, carrying, pushing, and pulling tasks.
  • Ability to work around ingredients, chemicals, allergens, airborne particles, vapors, moving mechanical parts, and potentially hazardous chemical or biological materials, and to wear respiratory, hearing, and other protective equipment when required.

Nice To Haves

  • Additional post-secondary education in a science field.
  • Prior team leadership experience.
  • Previous dietary supplement industry experience.
  • Bilingual verbal communication skills.

Responsibilities

  • Coordinate inspection activities on the assigned shift, including dispositioning materials.
  • Perform inspections and ensure adequate materials and supplies are available for sampling and inspection.
  • Delegate daily task assignments for the MQ Inspection team.
  • Conduct and document investigations, close nonconformance investigations within established timelines, and assist MQ Inspectors with investigations.
  • Assist with customer complaint investigations.
  • Conduct internal audits for cGMP compliance.
  • Track deviations and holds and ensure timely completion.
  • Perform root-cause analysis on manufacturing nonconformances and provide long-term preventive measures.
  • Assist Packaging and Processing departments with troubleshooting and resolving daily issues.
  • Coordinate rework with Production personnel and track lots on hold.
  • Assist management with monthly departmental metrics.
  • Identify and promptly notify management about actual or potential food-safety issues, and resolve issues within the scope of the role.
  • Train, mentor, and develop MQ employees, including new employees; follow up with team members and reinforce company policies, culture, and expectations.
  • Work with the supervisor to identify training gaps, incorporate them into training plans, and ensure employees are current on required training.
  • Review and update departmental standard operating procedures to ensure cGMP compliance.
  • Complete required documentation, including LIMS and Oracle entries; review records for completeness and GMP/SOP compliance.
  • Release materials for use and review associated documentation.
  • Participate in Tier II meetings when the supervisor and MQ Lead II are absent.
  • Assist with continuous improvement efforts to enhance safety, quality, production methods, equipment performance, and efficiency.
  • Support the skills development of MQ Inspectors and Samplers.
  • Comply with safety and GMP requirements; participate in safety activities, report incidents and hazards, use required PPE, and provide and accept safety feedback.
  • Collaborate with Production and cross-functional teams and communicate respectfully and effectively.
  • Work in any MQ Inspection area for which trained, according to departmental needs.
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