Quality Control Analytical Associate

General Responsibilities:

Performs testing in support of product manufacturing, employing manual and automated analytical equipment for cell count and cell viability testing, cell identity, flow cytometry, ELISA, endotoxin testing, collagen content determination, and sterility testing.

Responsibilities:

• Execute Analytical Test Methods for bulk intermediate testing and final product release testing.
• Execute testing for raw materials.
• Participate in the review process of SOPS and analytical test procedures as necessary to maintain compliance.
• Review of Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product. 
• Timely response to Out of Specification (OOS) results, including notification to area supervision.
• Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.
• Maintain housekeeping in the laboratories.
• Assist the Quality Control Supervisor in daily operations, as needed.
• Perform Growth Promotion testing on prepared media.
• Direct Sterile Media Fill Trials and perform support testing.
• Authoring and/or executing protocols and generating technical reports.
• Analytical method validation
• Equipment qualification
• Training of other employees
• Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented.

Computer Skills:            

• To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

Education:

• Minimum Bachelor of Science degree in a biochemistry, chemistry, or similar

Experience:

• 3-5 years Quality Control experience in a similar role in the biologics or pharmaceutical industry
• 2-3 years experience in mammalian cell culture in an academic or industrial laboratory
• Knowledge of basic laboratory skills (including aseptic technique, etc.) are required
• Knowledge of Current Good Manufacturing Practice and Industry standards
• Familiarity with analytical equipment including UV absorbance plate readers, Flow cytometers, microscopes and pH meters.
• Experience in aseptic processing and mammalian cell culture production
• Excellent verbal and written skills
• Good interpersonal communication skills
• Must be open to occasional off shift and weekend work