QC Analyst - 4 Cycle Shift (TEMPORARY)

Location: BioMarin – QC In‑Process | 4‑Cycle Shift Pattern

An exciting opportunity has arisen for a QC Analyst to join BioMarin’s 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 site. In 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 forms a part of a 4‑cycle shift team, supporting continuous manufacturing operations. This high‑performing, team‑based group values flexibility, multi‑skill and empowerment, while maintaining high standards of quality, compliance, safety and continuous improvement.

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• 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 BioMarin functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required
  
• Other duties as assigned
  

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• 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
  

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• BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience
  
• MSc with 3+ years of relevant cGMP laboratory experience
  

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

An Equal Opportunity Employer. xcfaprz All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.