Specialist QC, Bioanalytical Sciences

ADL QC Bioanalytical Sciences, Specialist QC

Overview:

This job specification outlines the general responsibilities associated with the role of QC Bioanalytical Sciences – QC Specialist on the Amgen Dun Laoghaire site.  This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, without direct supervision, acting as a role model for other lab colleagues.  The role undertakes providing technical expertise with a focus on method transfers, continuous improvement and implementing 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

• Expert in a wide variety of analytical techniques including but not limited to 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.
• Responsible for providing technical guidance and applying expertise and critical thinking to independently 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.
• Experience of managing project groups and leading high performing teams and delivering results
• Qualification of analytical equipment and related testing functions.
• Co-ordinates & plans activities related to the successful method transfers and optimisation of Bioanalytical Methods into the Amgen site. 
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Develop and 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 deviation procedures.
• Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Approval 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.

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.

Qualifications

• Excellent written and verbal communication skills
• Experience with TrackWise, Change Control Systems, Document Management Systems and SAP an advantage.
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interacting with inspectors
• Experience leading cross-functional teams
• Experience working with teams and influencing decisions
• 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 5-7 years of experience in a pharmaceutical/healthcare Laboratory.
• Proven experience of leading teams.
• Strong background in Bioassays, Immunoassays and Cell Culture is essential.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.