Compounding Lab Analyst
F. Hoffmann-La Roche Gruppe, Indianapolis, IN, United States
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).
The Opportunity
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.
Key Responsibilities
Instrument Management : Provides technical guidance on laboratory instrumentation, including implementation, replacement, and disposal.
Compliance & Calibration : Assesses instrument criticality and investigates out-of-calibration or out-of-tolerance (OOT) events.
Process Improvement : Authors and updates SOPs (Standard Operating Procedures) to support new product development and continuous improvement initiatives.
Quality Documentation : Participates in the investigation of non-conformances and the preparation of formal summaries and reports.
Training Support : Assists the Area Supervisor in developing and maintaining training curricula to ensure technician skills align with current cGLP regulations.
Inventory & Systems : Helps maintain raw material inventory accuracy and investigates system or process discrepancies to drive resolution.
Subject Matter Expertise : Leads continuous improvement projects and represents the functional area on Change Control Boards and new product development teams.
Analytical Problem Solving : Executes special projects related to analytical methodology and instrument troubleshooting.
Who You Are
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.
Preferred Qualifications
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.
This is an onsite role in Indianapolis. Relocation benefits are not available.
The expected salary range for this position based on the primary location of Indianapolis, IN is $66,850.00 - $124,150.00 Annual. Actual pay will be determined based on experience, qualifications, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long‑term incentive program. This position also qualifies for the benefits detailed at the link provided below.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form.
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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).
The Opportunity
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.
Key Responsibilities
Instrument Management : Provides technical guidance on laboratory instrumentation, including implementation, replacement, and disposal.
Compliance & Calibration : Assesses instrument criticality and investigates out-of-calibration or out-of-tolerance (OOT) events.
Process Improvement : Authors and updates SOPs (Standard Operating Procedures) to support new product development and continuous improvement initiatives.
Quality Documentation : Participates in the investigation of non-conformances and the preparation of formal summaries and reports.
Training Support : Assists the Area Supervisor in developing and maintaining training curricula to ensure technician skills align with current cGLP regulations.
Inventory & Systems : Helps maintain raw material inventory accuracy and investigates system or process discrepancies to drive resolution.
Subject Matter Expertise : Leads continuous improvement projects and represents the functional area on Change Control Boards and new product development teams.
Analytical Problem Solving : Executes special projects related to analytical methodology and instrument troubleshooting.
Who You Are
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.
Preferred Qualifications
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.
This is an onsite role in Indianapolis. Relocation benefits are not available.
The expected salary range for this position based on the primary location of Indianapolis, IN is $66,850.00 - $124,150.00 Annual. Actual pay will be determined based on experience, qualifications, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long‑term incentive program. This position also qualifies for the benefits detailed at the link provided below.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form.
#J-18808-Ljbffr