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QA Specialist - I //Foster City, CA with A Big Pharmaceutical Company
Ref No.: 18-56027
Location: Foster City, California
Position Type:Contract
Start Date / End Date: 10/15/2018 to 04/12/2019
Job Title: QA Specialist - I
Work Location: Foster City, CA
Length of Assignment: 6 Months
Position Type: Contract Role
Client: A Big Pharmaceutical Company


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.

If you are interested in this job than please send me your most updated resume on reena.sangwan@artech.com or you can reach me at #973-507-7579