QC Associate Senior

Job Title: QC Associate (Senior) Recruiter- Jessica Amaral

Our client, a multinational bio pharmaceutical company, is seeking a QC Associate (Senior) to join its expanding team in its Dun Laoghaire site, which includes a bio processing suite and laboratories.

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.

• 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.
  

Requirements

• Bachelor s degree in a Science related field is required.
  
• 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.
  
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
  
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  
• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
  
• Auditing documentation and operation process
  
• Demonstrated ability to interact with regulatory agencies
  

Benefits

• Benefit from Independent Solution s ethical principles.
  
• Pre-interview preparation before attending the interview and help to use STAR technology to answer the questions.
  
• While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross-functional Life Science team.
  
• We offer attractive rates - competitive margins compared to our competitors.
  
• Payment on time and in full.
  
• We are recognized as approved suppliers to leading key pharmaceutical and medical device companies.
  

If you have the above skills & experience, please contact or apply at

Independent solutions provide End to End solutions to the life sciences and we are expertise in Bio-Tech, Biopharma, and medical sectors. We are the sole source of exceptional Project managers, Engineering.