Sr Associate QC (Senior)

Team Horizon is seeking a CW QC Associate (Senior) for our client based in Dublin. 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.
 
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• 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.

 
What you need to apply:

• Cell based potency bioassays min experience, Cell culture, GMP/GDP Elisa


• Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology Biotechnology or similar Scientific Subject.


• Be very proficient in the use of Microsoft Word, Excel etc.


• Have strong technical writing skills.


• Be detail oriented, self motivated with good troubleshooting and problem solving abilities.


• Be a self starter and capable of working on own initiative.


• Strong team work skills.


• Proven track record of meeting deadlines.