Manager, Quality Control
Job in
Rosenberg, Fort Bend County, Texas, 77471, USA
Listed on 2026-06-02
Listing for:
LGM Pharma
Full Time
position Listed on 2026-06-02
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
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.
- 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.
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