Sr Associate Quality Control

Overview:

This job specification outlines the general responsibilities associated with the role of QC Senior Associate for the QC Bioanalytical Sciences laboratory on the Amgen Manufacturing site.  This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues.  The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers. 

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities:

• Experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture 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 Investigations and Deviations
• Participate in the generation and update of SOP’s, trend data, investigations, Deviations, 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.

Qualifications:

• Excellent written and verbal communication skills
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interaction with inspectors is preferable
• Experience leading cross-functional teams
• Experience working with teams and influencing decision
• Skilled in the use of problem-solving tools/techniques

Knowledge and Experience:

• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
• Strong background in Cell-Based Potency Bioassays, Immunoassays and Cell Culture is essential.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.