MANAGER, QUALITY CONTROL

MANAGER, QUALITY CONTROL

Rosenberg, TX Job Details Full-time 1 hour ago Qualifications Regulatory inspections Dissolution testing Stability testing Gas chromatography Budget management GLP Laboratory equipment maintenance High-performance liquid chromatographs Corrective and preventive actions (CAPA) GMP Laboratory equipment calibration 8 years Laboratory staff training Quality assurance audits Bachelor's degree Laboratory regulatory affairs Team management Task prioritization Scientific protocols Pharmaceutical analysis Staff training Laboratory quality control Chemistry Laboratory staff supervision Fourier-transform infrared (FTIR) spectroscopy Quality audits Laboratory budgeting Senior level Instrument maintenance Regulatory audits Communication skills Bachelor's degree in chemistry Stakeholder relationship building FDA regulations Health and safety training programs Full Job Description

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.