Quality Control Manager

Quality Control Manager

Skingenix, Inc -Job Location: Ontario, California

Company Description:

Skingenix Inc., a leader in dermal regeneration technologies, located in Ontario, California. As an innovative and mission-driven company, Skingenix pursues a standard of excellence in the regenerative medical industry with an emphasis on developing organ in-situ regenerative products for improving human health and quality of life.

Position Summary

Start with building cGMP compliance testing lab while working with CROs to fulfill the quality control function needs for the current stage of the project development. This role will ultimately responsible for implementing all Quality Control activities of Raw Materials, In-process, Finished Product and Microbiology sections to ensure that raw materials and finished products are promptly tested. Manage the operation of the Quality Control activities and CRO activities in terms of resource allocation (staff, equipment, materials and consumables), compliance, cGMP guidelines, and provide source and technique support to CROs and in house lab facility.

Essential Duties and Responsibilities

  1. Coordination of in house lab building, equipment procurement, instrument maintenance (service contract, consumable, supplies).
  2. Establish the in-house lab cGMP system. Develop and implement SOPs for various quality control operational procedures including training, trending, equipment maintenance and calibration, method execution, investigations, and laboratory processes.
  3. Performing hand on tests at the beginning stage of the lab establishment is required.
  4. Select, audit and work with CROs, coordinate test, contract, review protocol/raw data/report. Deal with CRO issues.
  5. Coordinates QC test (in house or CRO), ensure completeness, timeliness and overall cGMP compliance in all aspects of laboratory operations.
  6. Creates and revises raw material, component and finished product specification forms and worksheets based on company high level overall product quality profile design.
  7. Write method validation protocol, report and ensure the method validation is executed with compliance.
  8. Investigate out-of-specification results and write investigation reports.
  9. Perform data review, trending analyses and prepare protocols and report to support all areas of laboratory operations.
  10. Along with manufacture facility readiness, recruit and develop a high performing QC team. Conducts regular training for the quality control group.
  11. At the development stage of the product, work may involve some level of research work, some QA functionality job may be assigned.
  12. Performs other duties inherent of the position, and additional duties that may be assigned by supervisor.

Education, Knowledge and Skills Requirements

  1. Working experience in a pharmaceutical GMP settings. Candidate with Bachelor’s Degree requires 10+ years of relevant industry working experience, Master’s Degree requires 8+ years of relevant industry working experience, or PhD Degree with 5+ years of relevant experience.
  2. Experienced with state of the art analytical instruments, such as HPLC, GC, MS as well as routine analytical equipment, such as TLC, Wet chemistry.
  3. Familiar with compendia method and hand on experience with compendia methods is a plus.
  4. Knowledge of laws and regulations applicable to primary and secondary standards of measurements.
  5. Knowledge of the principles of cGMP, ICH as outlined by FDA.
  6. Knowledge of procedure and techniques used in calibrating and testing measuring instruments.
  7. Problem solving capability based on observations, technical procedures and test results.
  8. Detail-oriented. High degree of organization.
  9. Willingness to travel up to 10% to CROs, various meetings or training.