QC Bioanalytical Associate

at  PE Global

Skills:

• Cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique
• GMP experience
• Biochemistry experience
• Microbiology wouldn’t be considered
• Only interested in those with backgrounds in Biochemistry or Biotechnology.
• This team test products and sees how it reacts with cells in the body
• Will consider somebody with 1 years’ experience if the candidate is trained in GMP, or come through a role that involves a lot of research/critical thinking, with no GMP experienc

KEY RESPONSIBILITIES:

• Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Participate in regulatory agency inspections as required.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and quality goals.

Skills:

• Cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique
• GMP experience
• Biochemistry experience
• Microbiology wouldn’t be considered
• Only interested in those with backgrounds in Biochemistry or Biotechnology.
• This team test products and sees how it reacts with cells in the body
• Will consider somebody with 1 years’ experience if the candidate is trained in GMP, or come through a role that involves a lot of research/critical thinking, with no GMP experience