Quality Control Associate

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity

We are hiring QC Associate I to join our team, focusing on microbiology testing support. In this role, you will be responsible for:

• Core Responsibilities: Collect, process, analyze, and report data for samples associated with utilities, environmental monitoring (EM), cleaning validation/verification samples, and product samples. Execute and document routine and non-routine testing to support data generation, including bioburden, endotoxin, TOC, conductivity, and other general techniques according to established procedures.

• Compliance and Quality System Adherence: Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily. Ensuring compliance with GMP requirements through accurate testing, detailed documentation, and timely reporting of all results. Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation)

• Equipment Maintenance and Readiness: Maintain laboratory equipment and ensure proper calibration and documentation.

• Technical Support and Troubleshooting: Perform basic troubleshooting of microbiological and chemical assays and provide initial support for instrument issues to minimize downtime.

• Materials and Inventory Management: Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., media, reagents).

• Investigation and Data Review: Assist in data trending and data review for conformance to specifications/limits. Identify and escalate OOS, OAL, or atypical results. Support laboratory investigations, deviations, and CAPAs as needed.

• Training and Cross-Functional Liaison: Complete required onboarding and ongoing GMP/laboratory training within established timelines. Maintain training compliance and qualifications for all assigned methods and tasks. Assist in training and mentoring others in basics to complex laboratory tasks and troubleshooting techniques, as applicable. Participate in cross-training across microbiology and chemistry testing to support operational flexibility. Serve as a liaison for daily activities and special projects within QC or cross-functionally.

• Independent Execution: Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed
   

Who you are

• You possess a Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with 3-4 years of experience in GMP-regulated laboratory.

Knowledge, Skills, and Abilities 

• Strong attention to detail and data integrity mindset

• Good understanding of aseptic techniques and cleanroom practices.

• Work in office and laboratory environments.

• May work in the clean room environment that requires gowning and no make up or jewelry

• May work in the clean room environment where it is loud due to different equipment operating

• Work in office and laboratory environments

• GMP Execution & Compliance: Experience working in a GMP environment with the ability to read and follow Standard Operating Procedures (SOP) precisely. Possesses knowledge of laboratory safety procedures and basic experience supporting quality events.

• Data & Systems Proficiency: Proficiency with laboratory electronic systems, including LIMS and Microsoft Office.

• Agile Teamwork & Organization: Demonstrates excellent organizational skills and the ability to be agile and work independently in a fast-paced environment. Ability to adapt and work across multiple functional areas (cross-trained environment). Ability to manage multiple tasks and meet timelines.

• Quality Mindset & Communication: Excellent interpersonal, written, and verbal communication skills. Possesses a continuous improvement mindset and basic experience supporting audit or inspection activities.

• May be required to work overtime, some evenings and weekends
   

Physical & Work Environment Requirements