MANAGER, QUALITY CONTROL

PRIMARY DUTIES AND RESPONSIBILITIES:

• Write method validation protocols/reports and perform method development/validation/ verification for API and finished drug products.
• Familiar with analytical testing of raw materials, in-process samples, finished products and analytical laboratory instrumentation, such as HPLC, GC, CE, ICP, FTIR, TOC, dissolution apparatus, etc.
• Supervise the daily activities of the QC laboratory by establishing testing priorities and schedules and assignments of staff based on company priorities and objectives.
• Provide daily direction, guidance and feedback to staff based work priorities and schedules.
• Serves as scientific liaison to other facilities and departments and scientific/quality control member of Material Review Board.
• Assists with appropriate review of analytical results of completed raw material, stability samples, and finished product testing.
• Reviews and approves laboratory investigations, corrective and preventive actions, change requests, and deviations as necessary.
• Maintain equipment calibration schedule and ensure that all required calibrations and maintenance are completed in a timely fashion.
• Author standard operating procedures and assist with revision process of current procedures.
• Ensure laboratory compliance with applicable regulations.
• Assist with procedural, cGMP, and safety training of laboratory staff.
• Assist with preparations for internal and external (including FDA) laboratory audits and inspections.
• Administers annual laboratory budget and other related duties as required.

REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:

• Bachelors or higher degree in Chemistry or related discipline.
• 8+ years experience in a QC or Analytical chemistry laboratory.
• 3+ years experience in GLP or GMP (preferred) environment.
• Demonstrated ability to act in a Lead capacity and provide direction to others.
• Strong communication with ability to build relationships at all levels of the organization.
• Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.