Job Overview
QC Analyst – In-Process Control (Shift Role)
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 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.
Responsibilities
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
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
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.
Equal Opportunity Employer. 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.
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