Manager, Quality Control

Position: MANAGER, QUALITY CONTROL
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.