Senior Quality Control Analyst

AlphaVax, Inc. is seeking a talented Senior Quality Control Analyst for our Lenoir, North Carolina location. AlphaVax is a rapidly growing biotech vaccine company that is developing a new generation of human vaccines based on a unique viral vector delivery system.  The AlphaVax vector system constitutes a major advance in vaccine technology and has the potential to exert a significant influence on the future course of the vaccine industry. A broad- based immune response, safety profile, and protection data on challenge have been established in animal models and suggest that the vector system may stimulate immunity to diseases not currently preventable with vaccines.  Immediate applications of the technology include a variety of preventative and therapeutic vaccines for infectious diseases and cancer. 

 

OVERVIEW:

Quality Control senior analyst is responsible for coordination and execution of activities which support regulatory submission in the Quality Control laboratory in Lenoir.  These activities include: testing of components, in-process and release testing of drug substance and drug product of GMP manufactured lots; environmental monitoring; and compliance issues (calibration, maintenance, and documentation of equipment).  This person must possess experience in cGMP and have exceptional organizational skills.  This position will report to the Manager of Quality Control.

 

RESPONSIBILITIES:

· Oversee the activities of the laboratory analysts.

· Perform analyses as needed in support of studies.

· Reviews QC test results to ensure that specifications are met and that testing has been performed according to cGMP requirements.

· Schedule and perform supplementary analysis of samples for production lots for process residuals, potency and purity.

· Work with Quality Assurance to assure laboratory is compliant with respect to equipment, data tracking, SOPs/STMs and sample reconciliation.

· Assist in qualifying/validating assays for characterization of process intermediates and product.

· Write and/or revise SOPs and STMs, as needed.

· Perform other duties as required.

 

REQUIREMENTS:

· BS in biological science or equivalent; MS a plus.

· 5+ years progressive experience in a cGMP regulated environment working with quality control systems for a biotech/pharmaceutical/medical device company.

· Must have strong familiarity with cGMP and cGLP requirements.

· Previous experience should include reviewing data and compiling reports for assay qualification and optimization.

· Ability to monitor stability studies and interpret results.

· Must be detail oriented and have exceptional organizational and interpersonal skills.

 

AlphaVax offers competitive compensation, relocation assistance, an attractive benefits package, the opportunity for professional advancement, and career growth.  If you meet the position requirements and are seeking an opportunity to contribute in a challenging, small company environment, please submit a resume and salary history to email your resume to: humanresources@alphavax.com .  AlphaVax is an Equal Opportunity Employer.