QA Specialist III

Location
San Francisco, CA, United States
Posted
Jun 12, 2018
Ref
2-1-3244-420-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Performs a wide variety of activities to ensure compliance with applicable GMP requirements. Assures that all operations are performed in compliance with company procedures and Quality Standards. Coordinates site-specific Training activities. Collaborates with other sites to maintain oversight of computerized systems, such as electronic document management, training, and other quality system functions. Writes and revises standard operation procedures. Conducts investigations and manages change controls related to computerized systems. Generates reports. Applies knowledge of good manufacturing practices on a daily basis. Acts as System Administrator for ComplianceWire. Supports activities related to the company's Pharmaceutical Quality System. Assists in collecting training and document management Metrics.

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. 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 meetings. Reviews data audits and report reviews as required. Assists with identification of procedural and systematic compliance risk and recommends continuous improvements that complement functional area business processes. 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. Previous experience with computerized training systems is required, hands-on experience with ComplianceWire is highly preferred. 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 is 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.