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Quality Manager

2 months ago

Santa Fe Springs, United States NHK Laboratories, Inc. Full time

The NHK Labs name has become synonymous with quality, driven by decades of excellence in regulatory compliance, manufacturing, packaging, and customer service. We are a highly credentialed contract manufacturer and packager of dietary supplements, nutraceuticals, and functional foods seeking an experienced Quality Manager to join our team in Los Angeles to oversee our quality control, quality assurance, and R&D teams.


Responsibilities

  • Develop, implement, oversee, and evaluate NHK’s Quality Department, including Quality Assurance and Quality Control (QA/QC), Formulations/Quotations, R&D, and Regulatory Affairs programs, policies, initiatives, goals and objectives.
  • Lead QA, QC, and R&D activities and manage direct reports; delegate and adjust priorities for the team based on client needs.
  • Maintain quality systems to assure the continued conformity of products and compliance with established regulatory requirements, including current Good Manufacturing Practices (cGMPs), and SOPs.
  • Keep up-to-date with SOPs, and current industry and regulatory guidelines and regulations.
  • Communicate progress, problems, and plans as appropriate; elevate issues requiring attention to Leadership Team.
  • Ensure the highest operational, quality, and reliability standards adhere to industry best practices and regulatory requirements, from raw materials to finished goods
  • Ensure the identity, purity, strength, composition, and limits on contamination of raw material, in-process, and finished goods.
  • Create, update, and maintain testing specifications including raw materials, in-process, and finished goods.
  • Review and approve raw materials, packaging, and product specifications.
  • Oversee COA documentation, including review and approvals prior to product release.
  • Identify opportunities improve departmental and cross-functional processes and procedures to increase quality, efficiency, and effectiveness.
  • Collaborate with Marketing and Quality to ensure proper labeling of products; support Sales and clients with technical discussions and responses.
  • Maintain and enhance product quality documentation system by writing and updating quality assurance procedures such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
  • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
  • Participate in mock recalls, recalls, and withdrawals, including forward and backward traceability of raw materials and finished goods, respectively.
  • Participate in scheduled/random internal and external audits and quality control checks.
  • Participate Corrective Action Preventive Action (CAPA) policy and procedures including root cause analysis.
  • Lead investigations into customer complaints, adverse event deviation, returns, etc., process change controls or revise SOPs, as needed.
  • Conduct performance evaluations of Quality employees; train, coach, and counsel direct reports.
  • Trains, coaches, and counsels Quality employees in accordance with company policy.
  • Assists with efficient team operations and continuous process improvement, by participating actively in all team and departmental meetings as requested.
  • Collaborate cross-functionally (Operations, Sales, Finance, Research & Development), as needed


Qualifications

  • Expert knowledge of 21 CFR Part 11, 111, and 117 and 7 CFR 205 as it pertains to a dietary supplement manufacturing environment.
  • Hands-on experience with ICP-MS, Gas Chromatography, HPLC, FTIR, and other lab equipment
  • Hands-on experience with o R&D, Formulation and RFQ processes.
  • Bachelor's degree in a technical discipline such as Chemistry, Chemical Engineering, Microbiology, Food Science.
  • 5+ years of Quality experience within a GMP regulated industry, manufacturing environment preferred.
  •  Demonstrated history of cross-department collaboration on continuous improvement projects.
  • Demonstrated history of cross-department collaboration on continuous improvement projects.
  • Excellent organizational skills, including ability to handle multiple tasks, meet deadlines, and prioritize assignments with a focus on internal and external customer service.
  • Must possess excellent written and verbal communication skills.
  • Ability to effectively manage multiple, complex priorities.
  • Ability to work cooperatively in diverse teams and peer relationships.
  • Ability to communicate and present to external stakeholders, including clients, auditors, regulating agencies, etc.
  • Meticulous attention to detail including excellent proofreading skills.
  • Consistently demonstrates professional, positive, and approachable attitude/demeanor.