Head of Quality Control

Oversee day to day operations of the Quality Control Laboratory, Qualification and Development and Validation Departments while ensuring adherence to cGMP’s and CGLP’s and safety requirements, and provide senior technical leadership in Quality Control in order to enable the development, validation, and optimization of analytical methods in support of both internal pharmaceutical development and third party projects. Identify and implement systems needed in order to support Quality Control/Development activities in a regulated environment.  Ensure QC computer systems are validated and data integrity maintained at all costs.
 
This position is classified as a “safety sensitive” position and is subject to random drug testing.


Responsibilities to include, but not limited to:
 

• Assist when necessary, in patent reviews and or challenges.
• Oversee the day-to-day operations of the Analytical Services Laboratory, inclusive of raw material sampling and release testing and testing done in support of both internal pharmaceutical development and third-party fee for service client projects.
• Maintain timely reporting on Monthly Revenues, per established schedule.
• Continually improve the effectiveness of the Quality Control organization including:
• • Optimizing personnel and equipment utilization
  • Monitoring throughput
  • Streamlining testing
  • Working with other groups such as Business Services, Sales Services, Pharmaceutical Development, Manufacturing, Quality Assurance and New Business and Business Development with internal customers in resolving issues.
• Conduct internal and external audits for compliance and ensure adherence to cGMP’s/cGLP’s and safety requirements.
• Conduct internal audits to assess overall state of compliance of laboratory procedures and practices versus FDA standards, using observations to drive justifications for systems/equipment/personnel upgrades which are necessary to ensure compliance and support expansion of company business.
• Oversee laboratory change control process.
• Create and continuously monitor and update testing monographs.
• Approve analytical data generated in the laboratory.
• Lead the Quality Control Group in the development, validation, and optimization of analytical methods.
• Provide leadership in the routine and non-routine analytical testing required in support of third-party fee for service projects.
• Provide guidance and review of results summarized by scientists.
• Play a leadership role at cross-functional and management meetings.
• Ensure that all lab notebooks and related analytical reports are reviewed in a timely manner and data integrity be paramount as a standard.
• Work closely with associates in Pharmaceutical Development groups to ensure that critical data needed to assess process feasibility is available in a timely manner.
• Assist Process Pharmaceutical Development and Manufacturing groups on an as needed basis with design of evaluation protocols and preparation of reports documenting results of protocol based studies of process/formulation design.
• Participate in budgeting process in anticipation of future internal and third party pharmaceutical development projects.
• Represents Glatt Air Techniques at industry symposiums.
• Participates in journal article preparation and presentations at technical symposia on a regular basis.
• Participates in other work activities/responsibilities as required.