Quality Assurance Specialist I

Location
San Francisco, CA, United States
Posted
Jun 10, 2021
Ref
5352-340-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Quality Assurance Specialist I to join their team.

SUMMARY:

Performs a wide variety of activities to ensure compliance with applicable GXP requirements. Performs manufacturing batch record review. Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operation. Works to resolve production discrepancies. Writes, revises and reviews standard operation procedures and related manufacturing documents. May conduct investigations related to manufactured products. May also generate reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Assists with batch record review in support of lot disposition. Supports partner audits. Gathers and collates quality metric data. Assists with data audits and report review as required. Provides support to assure that appropriate quality and manufacturing systems are created, implemented and maintained for compliance with GLP, cGMPs and/or ISO standards. Supports in quality Supports in change control activities and compliance with cGMP requirements and SOPs. Supports in quality investigations utilizing QA tools and follows up on corrective actions to closeout. Supports in complaint handling and reserve sample management. Additionally, assists with supplier selection and monitoring and quality assurance agreement processes. Responsible for administering and maintaining department document control activities, including but not limited to folder management, monitoring of department email box, inputting department tasks into smart sheets/MS Excel, etc. Performs other duties as assigned.

REQUIREMENTS:

A minimum of a Bachelor's degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 1 year related experience is preferred. A minimum of 1 year experience in the pharmaceutical industry working in a GMP environment is preferred. Must have a demonstrated working knowledge of scientific principles. Requires strong oral and written communication skills. Knowledge of FDA regulations and cGMPs for drugs and device are a plus.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.