Associate Director Of Qc Microbiology

About this opportunity :

As an Associate Director of QC Microbiology, you'll manage overall QC laboratory operations including the development and implementation of systems, methods, policies/procedures for the testing and evaluation of materials, intermediates, API, drug product, and stability samples. Functions reporting to this position include raw materials, in-process manufacturing support, microbiology, analytical services, and release testing/stability for a shift-based operation.

Key Responsibilities:

• Provides leadership and communication on all quality control matters with both internal and external groups and customers.
• Actively participate in the development and oversight of Quality Control budget and resource planning.
• Assures the utilization of appropriate industry/regulatory standards and analytical tools to investigate any questionable results and develops/implements appropriate CAPA.
• Ensures test methods in use are appropriately qualified/validated, equipment is calibrated and maintained, and systems are in place to assure laboratory data is accurate, managed and retained per regulatory requirements.
• Develop and provide for training of staff.
• Ensures all QC activity are carried out in accordance with applicable SHE and CGMP policies and regulations.
• Develops and implements actions aimed at continuous improvement for the laboratory environment.

Required Skills/Abilities:

• The position requires experience working in a cGMP environment and experience with documentation and implementation of quality systems.
• Position requires a BS in Chemistry with 5-7+ years’ experience as a QC Manager in a pharmaceutical or Biotechnology organization.
• Experience leading teams of QC professionals is required.