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Quality Control Lab Manager

3 months ago

Azusa, United States Westwood Laboratories LLC Full time

SUMMARY: Westwood Laboratories Inc. is a leading contract manufacturer specializing in consumer and professional products within health and beauty, over-the-counter (OTC), pharmaceuticals, therapeutic drugs, medical devices, pet care, and personal care topical products. Established in 1948, Westwood Laboratories is an FDA-licensed pioneer in product development and quality custom manufacturing. Our dedicated professional team is committed to advancing cosmetic and drug formulations while providing unparalleled customer service.


We are seeking a dynamic Quality Control Manager to oversee all of Westwood Labs' analytical and microbiological testing. The ideal candidate will have extensive chemical, analytical, and microbiological experience to lead the site’s testing processes. The laboratory will perform analytical and microbiological testing of raw materials, in-process samples, and release testing of OTC drug products, personal care products, and cosmetics. The Quality Control Lab Manager will be responsible for developing and/or assessing methods for testing products manufactured at the site. These methods may be transferred from third-party laboratories to the Westwood labs for implementation. The Quality Control Lab Manager will oversee technology transfer, method development, qualification/ validation, and/or verification as per applicable guidelines.



JOB DUTIES AND RESPONSIBILITIES


The Quality Control Manager’s responsibilities will include, but are not limited to, the following:

  • Develop SOPs, guidelines, protocols, and reports that meet the requirements of GMP and appropriate regulations.
  • Develop and validate microbiological and analytical methods for testing raw material and formulated OTC, personal care, and cosmetic products.
  • Manage the day-to-day activities for all method development, transfer, validation, raw material, Bulk, and finished product testing.
  • Manage raw material supplier certificate of analysis qualification.
  • Manage OTC drug stability program per CHPA and ICH guidelines.
  • Assist with performing installation qualification, operational and performance qualification for new instrumentation.
  • Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility/integrity.
  • Facilitate the evaluation of new testing applications and instrumentation, including assisting in the purchase and commission of analytical instrumentation.
  • Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
  • Stay current on publications released by USP, FDA, and other pertinent regulating bodies to ensure activities throughout the facility are compliant and continuously improved upon.
  • Formulate a comprehensive lab contract service strategy and establish agreements with third-party laboratories to conduct required testing not performed in-house.
  • Manage budgets for service contracts, repairs, and equipment maintenance.
  • Implement efficient planning and scheduling to minimize equipment disruption.
  • Oversee asset life-cycle management with attention to budget efficiency.
  • Conduct thorough staff training and ensure the certification of competency.
  • Supervise work processes to guarantee precision and efficiency.
  • Ensure meticulous handling of testing samples from receipt to organization and preparation.
  • Address initial troubleshooting of testing issues and report problems promptly to leadership.
  • Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events.
  • Possess a deep understanding of ISO 17025 standards, Good Lab Practices, 21 CFR, US FDA guidance, and ISO 22716.
  • Ensure compliance with all requirements related to manufacturing, packaging, labeling, and distribution of finished OTC drug products.
  • Establish and ensure quality systems are maintained and function properly.
  • Monitor ongoing quality issues, determine needed changes, and drive the prevention of any new quality issues.
  • Provide supervision and leadership for lab personnel and carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
  • Ensure the laboratory team maintains the appropriate level of accountability for quality decisions.
  • Make fact-based, scientifically sound quality decisions regarding products manufactured based on cGMP and applicable regulatory/industry guidance.
  • Manage the release of raw materials, bulk and finished products according to the appropriate regulations and company policies and procedures.
  • Lead and/or support investigations, authoring, approving, and/or reviewing deviations, OOS and investigation reports and ensuring on-time completion of all corrective action items.
  • Oversight of creating, approving, and maintaining all applicable SOPs.
  • Other duties as assigned.


QUALIFICATIONS


  • Bachelor of Science in Chemistry or Life Science.
  • 5+ years of experience in the cosmetic/personal care industry.
  • 3+ years of experience in manufacturing OTC drug products – liquids preferred.
  • 2+ years in a managerial role managing a team(s) of Quality staff.
  • Understanding of microbiological testing as it relates to product compliance.
  • Knowledgeable of chemical testing with the ability to interpret and investigate abnormal results. Expert knowledge of cGMP requirements.
  • Expertise in the manufacture and control of finished OTC/cosmetic/personal care products.
  • Strong working knowledge of FDA requirements and guidance documents.
  • Working knowledge of the annual product quality review process, the self-inspection program, supplier qualification, and surveillance program to ensure audit and inspection commitments are adhered to, CAPA, change control deviations, SOP, quality agreements, and quality manual.
  • Experience developing, implementing, and maintaining quality systems.
  • Experience with developing/documenting procedures.
  • Excellent written and verbal communication skills.