QC Associate Director

Irvine, CA

Posted: 01/24/2020 Job Number: JN -012020-11347

Job Description

QC Associate Director

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: QC Associate Director
Location: Irvine, CA
Industry: Pharmaceutical
Hours: M-F, 8am-5pm (OT and weekends may be required)
Salary: $60-$66 per hour paid weekly with benefit options
Employment Type: 1 year with possible extension



Job Scope: Provides guidance and technical expertise to QC Chemistry personnel in all areas of Quality Control functions, including finished product, raw material and stability.


Responsibilities:
  • Oversee the Chemistry laboratory activities, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products (including stability).
  • Oversee/approve investigations, ensuring they are being conducted according to approved procedures and that corrective and preventive actions are implemented and effective.
  • Ensure QC documentation is handled and archived according to the relevant approved procedures.
  • Oversee and ensure adequate maintenance of the laboratory equipment and systems and monitoring of the laboratory environment.
  • Establish and implements departmental policies and ensures compliance to cGMP, cGLP, FDA, and other applicable regulatory guidelines.
Requirements:
  • B.S. in Chemistry with a minimum of 10 years of work experiences in Pharmaceutical Chemistry Laboratory or related industry.
  • Minimum of 10-15 years of work experience in Pharmaceutical Chemistry Laboratory or related industry. Minimum of 5-6 years of supervisory and management experience.
  • In-depth knowledge of cGMPs, GLP, USP, BP and EP Chemistry test methods and requirements and FDA, EMEA and other regulatory guidelines.
  • Thorough knowledge of Chemistry methods, lab equipment, and operation of LIMS system.
  • Excellent communication skills when communicating with senior management, colleagues, peers and management of other departments, etc. Possess good mentoring capabilities.

ADA/EOE
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