QC Lab Manager in Gilbert, AZ at Apex Life Sciences

Date Posted: 2/13/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a for a QC Lab Manager for a growing company in Gilbert, AZ!

General Description:

The Lab Manager is responsible to ensure material meets acceptable quality standards, safety, quality of our products, thereby ensuring the availability of accurate and safe product for Associates and customers. This includes developing, implementing and maintaining Lab QC systems to improve product quality and ensure products are produced in compliance with product standards, good Laboratory practices and in accordance with government regulations. In addition, this role will be required to provide guidance and consultation on QC tasks and manage lab staff to ensure adherence to GMP and 21CFRPART111 standards.

Responsibilities:

  • Manage the QC Laboratory including preparation of procedures and methods for testing products and managing the company QC laboratory. When applicable, develop QC laboratory method validations or determination of scientifically valid methods.
  • Oversee preparation of test samples for all raw material, intermediate (bulk and premixes) and finished product, with the goal of determining if the substance meets the standards and/or requirements of the project.
  • Create and manage test samples and testing requirements of raw materials and/or finished products performed by either in-house laboratories or contract laboratories.
  • Prepare documents that report the results of the tests and sends reports to Quality Assurance.
  • Manage and audit all contract laboratories.
  • Develop and implement process for managing the out-of-specification (OOS) and investigations from in-house QC and contract laboratories.
  • Manage the calibration and monitoring program for all in-house laboratory instrumentation.
  • Manage the product stability testing program and studies. Prepares routine reports.
  • Assure MSDS sheets are updated when applicable.
  • Review of raw material and finished product specifications during documentation review.
  • Train personnel working in the laboratory on SOPs, methods, processes, workplace safety and safe material handing as appropriate.
  • Keep company updated on any regulatory compliance changes in the industry that would affect the product test methods and/or product integrity.
  • Participate in regulatory inspections to explain the QC laboratory function.
  • Ensure the laboratory is properly equipped, provide recommendations for instrument acquisition and assume accountability for ensuring all laboratory systems are appropriately qualified and maintained.
  • Ensures that the lab is cleaned/sanitized and kept in an orderly manner.
  • Other projects and tasks as assigned.

Requirements:

  • Prior experience working in a cGMP/GLP environment required.
  • Solid understanding of manufacturing processes and troubleshooting.
  • Solid knowledge and proficiency with analytical methods currently used for purity, potency identity, and impurities testing for release and stability of nutraceutical products.
  • No dietary restrictions or allergies.
  • Must be a non-tobacco user and will not use tobacco products on or off the job during the tenure of employment in Quality Assurance, as it may affect taste accuracy testing.
  • Skilled in the use of Microsoft office software to include Word, Excel, PowerPoint, and Outlook.
  • Strong interpersonal skills, detail oriented and able to coordinate/manage multiple tasks simultaneously.
  • Must be able to work in a team environment and perform job responsibilities under minimal supervision.
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines

Education and Experience:

  • Bachelor’s degree in Science or Chemistry. Master’s preferred
  • 8 years of experience in laboratory environment, such as Dietary Supplements, Pharmaceuticals, or Cosmetics and 4 years of management experience.
  • Or, equivalent combination of education and experience. 

Please send your resume to phoenix@apexlifesciences.com.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.