IQC Technician II
Company: Disability Solutions
Location: Marana
Posted on: April 20, 2024
Job Description:
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
PositionThe 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.Who we areAt 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.
Keywords: Disability Solutions, Casa Adobes , IQC Technician II, Professions , Marana, Arizona
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