QC Sterility Analyst

21 hours ago

Cork, Ireland BIOMARIN Full time

QC Analyst - Sterility Team – 12 Month

Exciting 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/Behaviours

- Microbiological testing performed by the lab including: Growth Promotion and Biological Indicators
- Perform testing and review of primary packaging component testing
- Prepare protocols, summaries, and reports
- Draft QC SOPs
- Act as a technical resource (SME) and train other analysts in areas of expertise
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations to completion
- Maintain the laboratory in an inspection-ready state
- Interact directly with regulatory agency inspectors during audits
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Engineering, etc.) and contractors as necessary
- Excellent communication skills both written and verbal
- Customer focus; takes personal responsibility for speed, quality, and accuracy of delivery
- Self-motivated and ability to work under pressure
- Team Leadership – active participation in team development and continuous improvement including standard work and 5S
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
- Demonstrated adaptability and flexibility to support a growing organization
- Using systems such as Labware LIMS, MODA, and Veeva Quality Docs

Education

- B.S. in a scientific discipline with 3+ years of relevant laboratory experience

Experience

- Ability to work independently and meet established timelines
- Comfort with coordinating activities with other staff members
- Comfort with working in a team environment
- Knowledge of cGMPs
- Experience using quality systems such as Veeva
- Experience working with primary or secondary packaging is an advantage
- Experience with sterility testing is an advantage
- Experience with microbial methods is an advantage

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