SENIOR QUALITY ASSURANCE SPECIALIST

Location
Pasadena, CA
Posted
May 09, 2018
Required Education
Bachelors Degree
Position Type
Full time

GENERAL DESCRIPTION OF JOB:

This position is responsible for Quality Assurance activities which include providing daily quality assurance to operations, review batch records and production associated documentations within the manufacturing facility, provide support on Deviation, CAPA, OOS, and Change Control processes, and participate and support internal audits.

Assure compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory guidelines and company quality practice.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include but are not limited to:

  • Work with Manufacturing as the quality assurance representative
  • Coordinate and facilitate Quality Assurance related production and production related activities
  • Ensure timely review and closure of Deviations, CAPA, Change Controls, and OOS investigations
  • Review batch record and production related documentation, and ensure resolution of issues to release product
  • Ensure approval and timely shipment of Final Product
  • Ensure that products are manufactured in compliance with regulatory and GMP guidelines
  • Review and disposition raw materials, components for GMP use
  • Perform  periodical internal audit and identify all areas of weakness, provide recommendations to improve those areas, monitor the effectiveness of the improvements
  • Obtain resolution on areas identified as non-conformance. Assess and evaluate results in terms of acceptability to standards, procedures and regulatory requirements
  • Quality review of analytical and stability data
  • Fully comply with company health and safety procedures and practices

QUALIFICATIONS:

  • BS degree in Biology, chemistry or related discipline with 5+, MS Degree with 3+ years’ experience working in a Biotech or Pharmaceutical FDA regulated industry
  • Have an in-depth knowledge of FDA regulations, applications of current Good Manufacturing Practices (cGMP)
  • Be able to review and approve investigations
  • Have a strong interpersonal skill, great team player
  • Have strong organizational skills and ability to plan, follow-up, and implement tasks
  • Be able to work independently and with intermittent supervision
  • Be able to operate in a dynamic, fast paced cross-functional environment
  • Eligible to work in the US