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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

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 review, generation and sign-off of 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 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, investigates Out of Specification (OOS), and works independently with general guidance from senior team members.

The Opportunity

+ Perform inspection and testing of raw materials, in-process materials and finished goods in a compliant manner and 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 and performs routine maintenance of laboratory equipment outlined by operating procedures.

+ Perform regular laboratory and manufacturing environmental monitoring testing and perform and lab supply ordering and inventory management in order to support the QC laboratory and adherence to inventory control processes (TECO, Cycle counts, etc), including indirect materials, tissue kanbans, and retain samples.

+ Foster and follow an established safety culture, environmental guidelines and procedures for all work performed and formulate reagents with high complexity for material testing process.

+ Acts as QC representative in transferring processes from development to QC and may assist in coordinating vendor activities for user maintained laboratory equipment.

Who You Are

+ You hold a High School Diploma

+ You have 7 years relevant work experience, preferably in regulated industry.

Preferred** **Requirements

+ Associates or Bachelor’s Degree in Science or Life Science discipline.

+ 3 years work experience with an Associate’s Degree or less than 1 year work experience, entry level with a Bachelor's Degree.

+ Experience with handling corrosive and biohazardous reagents.

+ Experience working in GLP, cGMP or ISO regulated environments.

+ Experience with 6S and Lean techniques

Behaviors, competencies, and qualities of the ideal Quality Control Associate

+ 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 clear 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.

Physical conditions and PPE requirements

The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

+ The environment requires gowning, hair net, safety glasses, gloves and foot coverings.

+ Lifting up to 25lbs is required.

+ Schedules could include overtime and shift work in the future as business needs require.

+ Required to stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per day.

+ Required to push, pull, and lift a minimum of 25 pounds. Repetitive, consistent movements of the wrists, hands, and/or fingers.

+ Required to have good near visual acuity to perform activities throughout the processes in the assigned area.

The expected salary range for this position based on the primary location of Tucson, AZ is $48,000.00 - $89,200.00 USD Annual. 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 (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Are you ready to apply?

Relocation benefits are not eligible for this job posting.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

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 Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE\_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .