QC Associate Bioassay

• Under minimal supervision, responsible for one or more of the following activities in QC including: Reagent management, media preparation, GMP document review and management, sample and data management and some analytical testing.
• Contributes to team by ensuring the quality of the tasks/services provided by self.
• Contributes to the completion of milestones associated with specific projects or activities within team.

Skills required

• Cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique
• GMP experience
• Biochemistry experience
• Degree Science – Biochemistry or Biology (a must for the role)

Job Duties will include:

• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform routine tasks with efficiency and accuracy.
• Review, evaluate, back-up/archive, and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• May participate in lab investigations
• May interact with outside resources.

Knowledge:

Some experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique

• Bachelor's degree in a science discipline.
• 1 - 2 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry. xcfaprz
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.