Compounding Lab Analyst
About The Position
The Compounding Laboratory Analyst maintains and optimizes systems, processes, and instrumentation to ensure regulatory compliance and operational efficiency. This role performs internal assessments, resolves technical deficiencies, and upholds the Quality Management System (QMS) in strict adherence to Good Laboratory Practices (GLP). As a developing professional, the Analyst applies company policies to resolve a range of technical issues. The role involves managing projects of limited to moderate scope, exercising judgment within defined procedures, and collaborating with peers and stakeholders to achieve quality objectives.
Requirements
- Bachelor’s degree in a related scientific field (e.g., Chemistry, Biology, or Engineering).
- 2+ years of relevant laboratory experience.
- Strong foundational understanding of GDP, cGMP, and GLP standards.
- Solid grasp of technical principles, theories, and concepts related to analytical instrumentation.
- Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.
Nice To Haves
- Experience with Roche document management and Change Control processes.
- Strong analytical problem-solving skills with the ability to manage multiple tasks objectively and constructively.
- Familiarity with the Roche Asset Management (RAM) program.
Responsibilities
- Provides technical guidance on laboratory instrumentation, including implementation, replacement, and disposal.
- Assesses instrument criticality and investigates out-of-calibration or out-of-tolerance (OOT) events.
- Authors and updates SOPs (Standard Operating Procedures) to support new product development and continuous improvement initiatives.
- Participates in the investigation of non-conformances and the preparation of formal summaries and reports.
- Assists the Area Supervisor in developing and maintaining training curricula to ensure technician skills align with current cGLP regulations.
- Helps maintain raw material inventory accuracy and investigates system or process discrepancies to drive resolution.
- Leads continuous improvement projects and represents the functional area on Change Control Boards and new product development teams.
- Executes special projects related to analytical methodology and instrument troubleshooting.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
