Quality Control Analyst

Roche•Indianapolis, IN

5d•Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. As a QC Analyst at Roche, you serve as a vital guardian of product integrity, advancing science so that we all have more time with the people we love. In this role, you will go beyond routine testing to act as a consultant in the development of systems that improve compliance and business methods. By conducting formative internal assessments and resolving deficiencies, you will ensure our organization consistently meets the highest global standards while maintaining a steadfast commitment to excellence in every daily action. The Opportunity Conducts routine and non-routine analysis of raw materials and in-process and finished formulations according to standard operating procedures and quality program. Performs biochemical and/or chemical analyses of product to ensure stability. Compiles data for documentation of test procedures. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. ∙ Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities and revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Creates and maintains supporting software applications. Resolves technical issues that operators encounter during testing, driving improvements to the process if necessary. Performs non-standard analysis of data using appropriate statistical methods and applications as necessary. ∙ Trains new personnel and assists area Supervisor with developing/maintaining training curriculum to ensure skills of lab technicians remains current with new products and government regulations. Responsible for creating new area procedures and improving existing procedures to satisfy new product development and continuous improvements initiatives. Represents functional area as subject matter expert on relevant change control boards, new product development teams or other particular area that may require specific trainings and/or certifications. ∙ Responsible for coordinating the execution of pilot and validation studies. At times, actively participates in these studies and writes/develops protocols as necessary. Leads continuous improvement initiatives. Pro-actively consults / involves a more senior team member on individual cases or process steps. ∙ Perform correct processing and documentation for individual cases in the area assigned.

Requirements

Bachelor's degree in related field
3+ years of related experience
Complete understanding and wide application of technical principle, theories, and concepts in the field.
General knowledge of other related disciplines
Previous experience with and expertise in analytical testing and associated processes and equipment preferred
You are local to Indianapolis.

Responsibilities

Conducts routine and non-routine analysis of raw materials and in-process and finished formulations according to standard operating procedures and quality program.
Performs biochemical and/or chemical analyses of product to ensure stability.
Compiles data for documentation of test procedures.
Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary.
Participates in the preparation of investigations, summaries and reports.
Reviews data obtained for compliance to specifications and reports abnormalities and revises and updates standard operating procedures as needed.
May perform special projects on analytical and instrument problem solving.
Creates and maintains supporting software applications.
Resolves technical issues that operators encounter during testing, driving improvements to the process if necessary.
Performs non-standard analysis of data using appropriate statistical methods and applications as necessary.
Trains new personnel and assists area Supervisor with developing/maintaining training curriculum to ensure skills of lab technicians remains current with new products and government regulations.
Responsible for creating new area procedures and improving existing procedures to satisfy new product development and continuous improvements initiatives.
Represents functional area as subject matter expert on relevant change control boards, new product development teams or other particular area that may require specific trainings and/or certifications.
Responsible for coordinating the execution of pilot and validation studies.
At times, actively participates in these studies and writes/develops protocols as necessary.
Leads continuous improvement initiatives.
Pro-actively consults / involves a more senior team member on individual cases or process steps.
Perform correct processing and documentation for individual cases in the area assigned.