MANAGER, QUALITY CONTROL

LGM Pharma, LLC•Rosenberg, TX

About The Position

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 on work priorities and schedules. Serves as scientific liaison to other facilities and departments and scientific/quality control member of the 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 the 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.

Requirements

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

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 on work priorities and schedules.
Serves as scientific liaison to other facilities and departments and scientific/quality control member of the 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 the 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.