Quality Control Associate from Joulé

Santa Clara, CA 95050

About the Job

Join one of the world’s largest biotech companies, as well as a leading provider of in-vitro diagnostics and a global supplier of transformative innovative solutions across major disease areas.

Title of Position: Quality Control Associate
Location: Santa Clara CA
Pay Range: $25 - $31/hr.

Job Requirements:
HS Diploma Min. and 4 years of exp.
Associate's Degree: 3 years of exp.
BS Degree: 1+ years of exp.
• 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
• 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
• Experience with handling corrosive and biohazardous reagents

The Quality Control Associate – Sequencing Cartridge Operations will be an integral part of a team that performs cartridge assembly and systems testing. This individual will be responsible for the setup, execution, monitoring and data analysis of all Quality Control release activities

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 and investigates laboratory exception events and works independently with general guidance from senior team members

Requirements:
Education: HS Diploma Min. and 4 years of exp.
Associate's Degree: 3 years of exp.
BS Degree: 1+ years of exp.
Knowledge, Skills and Abilities
• 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
• 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
• 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 up to 25lbs may be required
•Environment may require gowning, hair net, safety glasses, gloves and foot coverings.
• May work with hazardous materials and chemicals

Responsibilities:

Performs setup, execution and monitoring of Sequencing process for the Quality Control release of cartridge assemblies.
Prepares sequencing platform equipment, test equipment and materials as required per procedure
Conduct data analysis of test results and determine Quality acceptability per approved procedures
Responsible for generating compliant QC documentation as part of the Device History Record, observations, test results and reports required for releasing items into inventory from the raw material to the in-process finished goods and final products.
Perform a variety of QC duties relating to production manufacturing, including incoming and in-process QC inspections
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
Assist in regular laboratory and manufacturing environmental monitoring testing
Assist in reagent and lab supply ordering and inventory management in order to support the QC laboratory
Ensures equipment is in compliance with calibration standards
Foster and follow an established safety culture, environmental guidelines and procedures for all work performed
May assist with troubleshooting and investigation of QC failures by working with others
May assist in transferring processes from development to QC
May assist in testing raw materials for reliability and stability
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 QC processes and laboratory equipment
Other duties as assigned

#M3

Salary

31 - 34 /year