QC Manager

2 weeks ago

Los Angeles, United States Xseer Pharmaceuticals Full time
Job DescriptionJob Description

Sr. Manager Quality Control

Xseer Pharmaceuticals, an FDA licensed outsourcing pharmaceutical 503B is seeking a full-time on-site QC Sr. Manager for our manufacturing facility located in Los Angeles, CA. The QC Manager will be responsible for developing and managing the QC staff and systems and overseeing all QC activities to ensure compliance with industry standards and regulations.

 

  • Provide Quality Control oversight for the facility startup, including qualification and validation activities.
  • Build GMP quality systems and the compliance infrastructure for the Quality Control labs.
  • Oversee lab instrument qualifications and test method transfers and qualifications.
  • Establish and maintain analytical assay performance trending program and reference standard trending program. Approve reports as per schedule.
  • Oversee management of product and materials stability programs
  •  Oversee equipment and instrument maintenance and calibration program to ensure testing execution to planned schedules.
  • Oversee material qualification program including materials risk assessments.
  • Lead inspections by FDA, or other regulatory agencies for Quality Control topics
  • Responsible for analytical testing for incoming raw materials and product release
  • Responsible for use of laboratory/analytical equipment 
  • Responsible for Environmental Monitoring program
  • Responsible for compounding operator training content and respective compliance
  • Trains operators in aseptic processing from gowning and entry to critical steps involving aseptic filling, crimping, lyophilization load/unload, and more.
  • Reduces waste by cGMP/QC assessments via feedback corrective action.
  • Responsible for comprehensive quality rejects. Identifies and segregates defective units according to defect type and notifies appropriate department when necessary. Identifies gaps or deficiencies in production and creates & assigns training accordingly.
  • Creates processes and SOPs to ensure compliance, streamline efficiencies, and minimizes waste. 
  • Have strong understanding of cGMP as it pertains to a sterile injectable drug manufacturing facility.
  • Review and approve all analytical documents weekly, responsible for the accuracy and quality of all analytical QC methods, and many QC documents, ensuring that they meet regulatory and industry standards.
  • Develop project plans, including timelines, resource and material demands, and deliverables, for analytical method implementation and validation.
  • Ensure that project timelines and deliverables align with the company's broader project timelines. 
  • Strong Analytical Technical Knowledge: Success in this position hinges on a deep understanding of analytical methodologies, including the ability to grasp and apply various analytical methods swiftly. A robust foundation in analytical science is essential for making.
  • Critical Document Review with the responsibility to review and approve hundreds of QC documents, meticulous attention to detail and the capacity to critically assess data and reports is non-negotiable. Ensuring the highest standards of quality and compliance.
  • Provide technical expertise during laboratory investigations such as CAPA, OOS and OOT.

 

Qualifications:

 

  • M.S. in related field and minimum of three years related experience or B.S.in related field and minimum of five years related experience.
  • Strong knowledge of compounding manufacturing processes, equipment validation, GMPs, and product/process validation.
  • Expertise in FDA regulations and cGMP guidelines.
  • Knowledge of and ability to utilize statistics in evaluation of data.
  • Knowledge and experience of USP, , and regulations.
  • Experience with laboratory environment, equipment, and safety procedures.
  • Excellent written and oral communication skills.
  • Strong organizational, problem-solving, interpersonal, and analytical skills.
  • Ability to manage priorities and workflow.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Experience creating and implementing analytical method validation.
  • Demonstrate a strong knowledge of analytical test methods and instrumentation.
  • Ability to lead, train, develop, and motivate the team.
  • Able to work independently, prioritize competing demands, and meet deadlines.

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