QC Analyst

Overview:

• An exciting opportunity has arisen for a QC Analyst to join QC In Process Control team based in a newly 5S certified analytical laboratory. This role offers excellent exposure across both Drug Substance and Drug Product manufacturing in a fast paced highly compliant GMP environment.
  
• The QC In Process team delivers comprehensive in process analytical and microbiological testing supporting manufacturing operations across the addition the team performs testing of incoming raw materials and packaging materials to support downstream pack line activities.
  
• Due to the critical around the clock nature of in process testing this role is part of a 4 cycle shift team supporting continuous manufacturing operations.
  
• QC In Process is a high performing team based group where colleagues are flexible multi skilled and empowered to make decisions. The team operates to an exceptionally high standard of quality compliance and safety with a strong focus on continuous improvement standard work and 5S.
  
• This role requires a high level of initiative energy and motivation together with strong organisational skills and the ability to thrive in a dynamic manufacturing environment.
  
  

Requirements

Role Responsibilities:

• Reporting to the QC Team Lead the QC Analyst is responsible for supporting internal customers by delivering high quality compliant test results in accordance with GMP standards.
  
  
• Key responsibilities include but are not limited to:
  
• Perform primary review of QC raw data and trend results
  
• Prepare protocols summaries and reports including documents submitted directly to pharmaceutical regulatory agencies
  
• Draft and update QC Standard Operating Procedures (SOPs)
  
• Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise
  
• Evaluate analytical and microbiological results against defined acceptance criteria
  
• Conduct and document laboratory investigations through to completion
  
• Maintain the laboratory in a constant state of audit and inspection readiness
  
• Interact directly with regulatory agency inspectors during audits and inspections
  
• Interface with other functions including Manufacturing Quality Assurance Facilities and external contractors as required
  

Other duties as assigned:

• Desirable Skills and Attributes
  
• Excellent written and verbal communication skills
  
• Strong customer focus with personal accountability for speed quality and accuracy of delivery
  
• Self motivated with the ability to work under pressure in a fast paced environment
  
• Team oriented with active participation in team development and continuous improvement including standard work and 5S
  
• Demonstrated success in achieving goals as part of a high performing team in a growing organisation
  
• Proven adaptability and flexibility to support an evolving operational environment
  

Education and Experience:

• BSc in a scientific or engineering discipline with 5 years of relevant cGMP laboratory experience
  or
  
• MSc with 3 years of relevant cGMP laboratory experience
  
• Shift Pattern: 24/7 shift (2 Weeks Days and rotating to 2 week Nights)
  
• 12 Month of contract with an possibility of an extension