Quality Assurance Specialist III

Location
San Francisco, CA, United States
Posted
May 23, 2021
Ref
5356-420-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

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

Performs a wide variety of activities to ensure compliance with applicable GMP requirements. Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operations. Writes and revises standard operation procedures and related manufacturing documents. Conduct investigations related to manufactured products. Generates reports. Applies knowledge of good manufacturing practices on a daily basis. May also support various project development teams by providing quality oversight of development activities.

Essential Duties and Responsibilities:

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments. Participates in the disposition of batches, including resolution of investigations and deviations to meet lot release timelines and disposition as designated. Performs batch record review and disposition as designated. May interface with pharmaceutical partners on quality and product issues, and FDA during cGMP audits. May participate in the performance of internal and external audits in accordance with current regulatory compliance. Assists with quality investigations utilizing QA tools and following up on corrective actions to closeout. Assists with Quality Oversight activities for Contract manufacturing organizations (CMOs), through the review process and participation in regular meeting. Reviews data audits and report reviews as required. Assists with identification of procedural and systematic compliance risk and recommend continuous improvements that complement functional area business processes. May approve specific procedures, master batch records, specifications and critical process parameters, discrepancy investigations and batch release as designated by higher level. Provides support to other projects as assigned.

Requirements:

A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 5 years related experience is required. A minimum of 4 years experience in the pharmaceutical industry working in a GMP environment is required. A demonstrated working knowledge of scientific principles is a must. Strong oral and written communication skills are required. A thorough knowledge of FDA regulations and cGMPs for drugs and device are a must.

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.