Quality Assurance Specialist III

4 weeks ago

Huntsville, United States Nektar Therapeutics Full time

The Quality Assurance Specialist III works on 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 over sight of development activities.

 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 time lines 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.

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.

Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses). Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. Huntsville, AL only: Employee must be able to pass drug screening for employment consideration.

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