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The Quality Control Associate – Reagent Manufacturing will be an integral part of a team that performs raw material and finished goods testing.  The individual will be responsible for reviewing, generating, and signing off quality documentation.  

The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment.

The individual will maintain areas in a high state of inspection preparedness by maintaining equipment, records, and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). 

Additionally, maintains production documents to investigate laboratory exception events, and works independently with general guidance from senior team members

Your Opportunity:

● Perform inspection and testing of raw materials, in-process materials, and finished goods in a compliant manner.

● Document test results, complete batch records, document observations and generate reports for qualification testing.

● Conduct data analysis of raw material, in-process, and finished goods test results.

● Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods.

● Maintain records and QC lab environment to comply with cGMP, OP, and regulatory requirements.

● Support 6S effort and continuous improvement to streamline overall operations and improve efficiency.

● Assist in performing maintenance of laboratory equipment, and in regular laboratory and manufacturing environmental monitoring testing.

● Assist in reagent and lab supply ordering and inventory management to support the QC laboratory.

● Ensures equipment complies with calibration standards.

● Foster and follow an established safety culture, environmental guidelines, and procedures for all work performed.

● Assist with troubleshooting of failures in Manufacturing Exception Events by working with others.

● May assist in transferring processes from development to QC

● May assist in testing raw materials for reliability and stability, process monitoring and trending, collecting, interpreting, and communicating process metrics for recommended improvements.

● May assist in performing, reviewing, and/or generating validations for QC processes and laboratory equipment.

● Assist in the development and implementation of testing processes.

● Assist in reagent manufacturing activities unrelated to QC activities.

Other duties as assigned by management.

Who you are?

Minimum requirements:

High School diploma required (Associate's or Bachelor's degree preferred).

7 years of related experience with a High School Diploma (required); or 3 years of related experience with an Associate’s degree less than a year of experience entry level with a Bachelor's Degree (preferred).

Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving testing, investigations, and theory.

Strong data analysis skills, with a clearly demonstrated understanding of analytical, troubleshooting, and problem-solving skills.  Proven math skills

Hands-on experience in a laboratory

Accurate and precise manual pipetting and measuring techniques

Demonstrated attention to detail and strong organizational skills

Ability to utilize electronic office suite of computer programs

Proven ability to meet deadlines and work under aggressive timelines

Demonstrated ability to work effectively in a team environment

Knowledge, Skills, and Abilities

Experience working in GLP, cGMP, or ISO-regulated environment

Experience with 6S and Lean techniques

Experience with handling corrosive and biohazardous reagents

Work is performed in a laboratory environment

Schedule could include overtime and shift work in the future as business needs require

Lifting to 25lbs may be required

The environment may require gowning, a hair net, safety glasses, gloves, and foot coverings.  May work with hazardous materials and chemicals

The expected salary range for this position based on the primary location of Tucson, AZ is 48,000.00 - 89,200.00 USD annually.

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

Schedule: 8:00 am to 5:00 pm M - F

Are you ready to apply?

Relocation benefits are not available for this position.

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.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

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.