The Incoming Quality Control (IQC) Technician - Instruments Manufacturing, will be an integral part of a team that performs inspection of raw materials, components and sub-assemblies using established operation procedures, work instructions, engineering parts drawings. The individual will be responsible for the review, generation and sign-off of inspection reports and related quality documentation.The individual will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and GMP manufacturing environment.The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and IQC environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP).Additionally, maintains incoming inspection documents, assists in the investigation of incoming parts and instruments manufacturing non-conforming parts, manufacturing exception events and works independently with general guidance from senior team members.

Responsibilities

• Perform inspection and testing of incoming materials and parts in inventory when an inventory sort is required and of engineering samples and supplier first articles

• Document inspection results, complete records, document observations and generate reports for qualification testing

• Conduct data analysis of inspected materials results

• Responsible for generating compliant IQC documentation as part of the SAP QM Records required for releasing items into SAP inventory from the incoming material and in-process and inventory sorted parts

• Execute accurately and on a timely manner all the required SAP inventory transactions related to the inspected materials to ensure the integrity of the inventory locations.

• Maintain records and IQC lab environment to comply with GMP, OP and regulatory requirements

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

• Assist in performing maintenance of laboratory equipment

• Assist in regular IQC laboratory and manufacturing environmental monitoring testing

• Assist in tools and IQC lab supplies ordering and inventory management in order to support the IQC laboratory

• Ensures equipment is in compliance 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 inspecting incoming materials for reliability

• May assist in process monitoring and trending

• May assist in collecting, interpreting and communicating process metrics for recommended improvements

• May assist in performing, reviewing and/or generating validations for IQC processes and laboratory equipment

• May assist in the development and implementation of inspection/testing processes

• May assist in reagent manufacturing activities unrelated to IQC activities

• Other duties as assigned by management.

Minimum Qualifications:

High School Diploma required (Associate's Degree or Bachelor's Degree preferred)

Experience:

5 years of related experience with a High School Diploma (3 years of related experience with an Associate's Degree or Less than 1 year of experience entry level with Bachelor's Degree preferred)

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding reporting and resolving incoming inspection issues and SAP inventory control investigations.

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

• Hands on experience in a metrology laboratory

• Accurate and precise manual 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

• Experience working in GLP, cGMP or ISO regulated environment

• Experience with 6S and Lean techniques (preferred)

• Schedule could include overtime and shift work in the future as business needs required (preferred)

• Lifting up to 25lbs may be required (preferred)

• Environment may require the use of personal protection equipment (PPE) such as safety glasses, gloves and foot coverings.

Relocation benefits are not available for this job posting.

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.

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