SUPERVISOR, QUALITY CONTROL LAB

LGM Pharma, LLC•Irvine, CA

About The Position

RESPONSIBILITIES: Supervises the daily activities of the QC laboratory by establishing testing priorities and schedules and assignments of staff. Provides daily direction, guidance and feedback to employees based on work priorities and schedules. Assures appropriate review of analytical results commensurate within the company review policy. Conducts employee performance review, compensation reviews and new employee recruitment. Supervises and performs laboratory investigations. Maintains equipment calibration schedule and ensures that all required calibrations and maintenance are completed in a timely fashion. Authors standard operating procedures and assist with revision process of current procedures. Ensures laboratory compliance with applicable regulations. Performs and/or assists with procedural, cGMP, and safety training of laboratory staff. Acts as communication liaison for laboratory with other facility departments. Serve as backup for laboratory Management. May performs analytical testing of raw materials, in-process samples, and finished products using analytical laboratory instrumentation, such as HPLC, GC, CE, ICP, FTIR, TOC and dissolution apparatus as necessary. Assists with preparations for internal and external laboratory audits and inspections. Other related duties as required.

Requirements

Bachelor’s or higher degree in Chemistry or related discipline, or equivalent combination of education and experience.
8 + years’ experience in a GMP analytical chemistry laboratory, including analytical instrumentation, such as HPLC, GC, CE, ICP, FTIR, TOC and dissolution apparatus.
Demonstrated ability to act in a Lead capacity and provide direction to others.
Ability to build relationships at all levels of the organization.
Strong communication and demonstrated listening skills.
Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
Strong attention to detail.

Responsibilities

Supervises the daily activities of the QC laboratory by establishing testing priorities and schedules and assignments of staff.
Provides daily direction, guidance and feedback to employees based on work priorities and schedules.
Assures appropriate review of analytical results commensurate within the company review policy.
Conducts employee performance review, compensation reviews and new employee recruitment.
Supervises and performs laboratory investigations.
Maintains equipment calibration schedule and ensures that all required calibrations and maintenance are completed in a timely fashion.
Authors standard operating procedures and assist with revision process of current procedures.
Ensures laboratory compliance with applicable regulations.
Performs and/or assists with procedural, cGMP, and safety training of laboratory staff.
Acts as communication liaison for laboratory with other facility departments.
Serve as backup for laboratory Management.
May performs analytical testing of raw materials, in-process samples, and finished products using analytical laboratory instrumentation, such as HPLC, GC, CE, ICP, FTIR, TOC and dissolution apparatus as necessary.
Assists with preparations for internal and external laboratory audits and inspections.
Other related duties as required.