What are the responsibilities and job description for the Quality Control Analyst position at Roche?
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
We advance science so that we all have more time with the people we love. Provides a consulting role in the development of new or revised systems to improve business unit regulatory compliance and/or business methods. Accomplishes formative internal assessments to determine compliance level of the organization to regulations and standards and to develop systematic methods to resolve any deficiencies. Learning and developing professional expertise. Applies company policy and procedures to resolve a variety of issues. Works on projects of limited to moderate scope. Exercises judgement within defined procedures and practices. Receives general instructions on routine work, detailed instructions on new projects or assignments. Interacts with peers and stakeholders as required to complete tasks. Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions
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.
Who You Are
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
Relocation benefits are not available for this posting
The expected salary range for this position based on the primary location of Indianapolis, IN is $61,900 - $114,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Salary : $61,900 - $114,900