QA Specialist III, Quality Assurance

Location
Huntsville, AL, United States
Posted
Jun 29, 2018
Ref
2-3321-420-R
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Performs a wide variety of activities to ensure compliance with applicable GXP/DEA requirements. Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operations. Writes, revises, reviews, and approves standard operation procedures and related manufacturing documents. May conduct investigations related to manufactured products. Applies knowledge of good manufacturing practices on a daily basis. May also support various project development teams by providing quality over sight of development activities. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Acts independently to determine methods and procedures on new assignments. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Uses professional concepts to achieve objectives in creative and effective ways. Performs batch record review, including resolution of investigations and deviations to meet time lines. Performs lot disposition. Interfaces with pharmaceutical partners on quality and product issues, and FDA during cGMP audits and DEA during CDS audits. Participates in the performance internal and external audits in accordance with current regulatory compliance. Participate in Quality investigations utilizing QA tools and follows up on corrective actions to closeout. Participates in Quality Oversight of Contract manufacturing, acting as person-in-the-plant. Performs data audits and report reviews as required. Identifies procedural and systematic compliance risk and recommends practical corrective actions that complement functional area business processes. Reviews regulatory filings. Develops and delivers training courses. Approves specific procedures, master batch records, specifications and critical process parameters, discrepancy investigations and batch release as designated by higher level. Performs CDS program activities.

Requirements:

This position requires the minimum of a Bachelors degree in a scientific discipline. 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. An in-depth knowledge of FDA regulations and cGMPs for drugs are a must. Previous supervisory experience is preferred.

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.