QC Analyst - Sterility Team – 12 MonthExciting new role in the newly approved sterility test lab within the QC team at BioMarin.
This role will be focused on supporting primary component packaging, microbiology, and sterility testing to support the new Drug product facility in BioMarin.
QC Sterility is a high-performing, team-based group.
The team is dynamic and works cross-functionally on-site with various other departments supporting routine testing, investigations, project work, and providing SME guidance.
Members of the team are empowered to make decisions.
A high level of initiative, energy, and motivation are key role requirements, as well as organizational skills.
The role of the QC analyst will include executing testing of primary packaging components for use in the Drug Product facility and routine tests in the QC Sterility team to support drug product operations.
Skills/Knowledge/BehavioursMicrobiological testing performed by the lab including: Growth Promotion and Biological IndicatorsPerform testing and review of primary packaging component testingPrepare protocols, summaries, and reportsDraft QC SOPsAct as a technical resource (SME) and train other analysts in areas of expertiseEvaluate results against defined acceptance criteriaConduct and document laboratory investigations to completionMaintain the laboratory in an inspection-ready stateInteract directly with regulatory agency inspectors during auditsInterface with other BioMarin departments (Manufacturing, Quality Assurance, Engineering, etc.)
and contractors as necessaryExcellent communication skills both written and verbalCustomer focus; takes personal responsibility for speed, quality, and accuracy of deliverySelf-motivated and ability to work under pressureTeam Leadership – active participation in team development and continuous improvement including standard work and 5SSuccessful track record in achieving goals as part of a team within a growing, dynamic environmentDemonstrated adaptability and flexibility to support a growing organizationUsing systems such as Labware LIMS, MODA, and Veeva Quality DocsEducationB.S.
in a scientific discipline with 3+ years of relevant laboratory experienceExperienceAbility to work independently and meet established timelinesComfort with coordinating activities with other staff membersComfort with working in a team environmentKnowledge of cGMPsExperience using quality systems such as VeevaExperience working with primary or secondary packaging is an advantageExperience with sterility testing is an advantageExperience with microbial methods is an advantage
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