What are the responsibilities and job description for the MANAGER, QUALITY CONTROL position at LGM Pharma, LLC?
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.