Quality Assurance Associate

Location
Concord, California
Posted
May 07, 2018
Required Education
Bachelors Degree
Position Type
Full time

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards.Will provide GMP, GLP, and ISO 13485 compliance support as necessary.

Primary Responsibilities:

  • Register Technical Product Complaints (TPCs), monitor timely investigations, prepare customer letters, and ensure timely closure
  • Perform trending and data analysis for meetings / reports
  • Provide support for Regulatory authority and customer requests regarding complaints
  • Audit study reports and raw data for compliance with protocols, SOPs and regulations.
  • Review manufacturing, QC, release records, and documentation.
  • Write/revise/review SOPs/INSs as necessary
  • Provide risk assessment expertise for internal projects and processes.
  • Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
  • Perform internal and supplier quality audits and facilitate corrective actions
  • Identify compliance weaknesses and ensure the implementation of workable solutions.
  • Perform other related duties as required..

    Qualifications/Requirements/Skills:

  • Bachelor’s degree or equivalent in a scientific discipline with a minimum of 5 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 3 years’ experience.
  • Minimum 3 years’ experience in regulated operations.
  • Strong understanding of the FDA GMP regulations and ISO 13485; GLP/GCP experience is a plus.
  • Ability to exercise independent judgment.
  • Strong data review and technical writing skills.
  • Direct experience with product complaint handling, including investigation and documentation
  • High-level understanding of scientific approach and analytical thinking of others.
  • Strong communication skills (encompasses verbal, written, interpersonal, listening).
  • Ability to influence others.
  • High level of attention to detail and accuracy; very observant in order to audit properly.
  • Flexible; ability to adapt to changing priorities.

Excellent time management skills (schedules, timelines, task prioritization).