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QA Specialist - I
Ref No.: 18-15142
Location: Foster City, California
Position Type:Contract
Start Date / End Date: 10/15/2018 to 04/12/2019
 
Job Title: QA Specialist - I
Duration: 6 months
Location: Foster City, CA- 94404
 
 
Job Description:
 
  • Authors annual product quality review (APQR) report in compliance with FDA and international health agency requirements.
  • Coordinates data and information collection for APQR.
  • Supports investigations by working directly with operating entities and internal clients with  assistance from management and/or more senior level investigators to ensure follow-up of quality  issues.
  • Participates in cross-functional meetings with internal and external parties as required.
  • Supports APQR review process through development and generation of quality system metrics and trending, and escalate issues as required.
  • Conducts or serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations.
  • Responsible for maintaining tracking tools/databases.
  • Supports the maintenance and improvement to quality systems processes, as needed.
  • Participates in the development of training programs regarding all aspects of producing quality  products, as required.
  • Assists in compliance audits as required.
  • Participates in developing standard operating procedures to ensure quality
  • Maintains programs and processes to ensure high quality products and compliance with current
  • Good Manufacturing Practices (cGMPs).
 
Essential Duties and Job Functions:
 
  • Authors annual product quality review (APQR) reports.
  • Presents and explains process/product performance to multiple internal audiences.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory  requirements.
  • Participates in developing standard operating procedures (SOPs) to ensure quality objectives are met.
  • Maintains routine programs and processes to ensure high quality products and compliance with current good manufacturing practices (cGMPs) and good laboratory practices (GLPs).
  • Reviews manufacturing and quality control data for in-process and finished products as needed and escalate as required.
  • Supports operating entities in efforts to continuously improve process and systems.
  • Normally receives very little instruction on routine work, general instructions on new assignments.
 
Knowledge, Experience and Skills:
 
  • Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs) and/or
  • Good Laboratory Practices (GLPs).
  • Demonstrates working knowledge of quality assurance systems, methods and procedures.
  • Demonstrates knowledge of regulatory authorities standards and quality systems.
  • Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools.
  • Demonstrates report writing skills, audit, investigation, and data analysis skills.
  • Demonstrates good verbal, written, and interpersonal communication skills.
  • Demonstrates proficiency in Microsoft® Office applications; especially Microsoft Word and Excel.
  • Prior experience in pharmaceutical industry is preferred

Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331