QA Specialist II

Location
Huntsville, AL, United States
Posted
Mar 25, 2019
Ref
3444-420-2019
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Performs a wide variety of activities to ensure compliance with applicable GMP requirements.

Participate and provide support in the release of raw materials .Performs manufacturing and packaging batch record and analytical data pack reviews. Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operations. 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. May also support various project development teams by providing quality over sight of development activities. Applies knowledge of good manufacturing practices on a daily basis.

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. Participates in the disposition of batches, including resolution of investigations and deviations to meet lot release time lines. Conduct manufacturing and packaging batch record review. Performs line clearance and checks for product and packaging activities. Supports and performs Document Control activities in order to ensure compliance within the controlled document management system both electronically and manually. Maintain batch related documentation including but not limited to issuance and maintenance of batch records, labels, logbooks, spreadsheet tracking logs. Perform Document Control Functions (i.e. scan, photocopy, distribute, file, and archive, etc…). May provide training to new employees and helps maintain the Training program. . Compile Product Quality Reports (i.e. annual product reports, batch review summary report). Contribute to quality improvement initiatives. Supports partner audits. Gathers and collates quality metric data. Participates in regulatory inspections by assisting in the coordination of readiness activities and inspection logistics. May participate as person-in-the-plant. Performs data audits and report review as required. Supports in quality investigations utilizing QA tools and follows up on corrective actions to closeout. Performs other duties as assigned.

A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 2 years related experience is required. A minimum of 1 year experience in the pharmaceutical industry working in a GMP environment is required. Must have a demonstrated working knowledge of scientific principles. Requires strong oral and written communication skills. Knowledge of FDA regulations and cGMPs for drugs are a must. Attention to detail. Ability to work and coordinate activities with multiple functional groups with sense of urgency. Ability to organize, prioritize, plan and schedule. Ability to work with minimal supervision.

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.