Job Description :
Senior Scientist, Quality Control
6 Months
San Jose, CA
Summary: The Senior Scientist, Quality Control – Reagent Manufacturing will be an integral part of a quality team that performs raw material, finished goods subassembly qualification testing and data-analysis for reagents for the Harmony test. 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 ISO13485 and soon to be 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 Standard Operating Procedures (SOP
Essential Responsibilities:
Perform inspection and testing of raw materials and in-process finished goods subassemblies right first time in a compliant manner
Conduct data analysis of raw material and in-process finished goods subassemblies test results
Review QC records and generate Certificate of Analysis for finished products
Formulate reagents with high complexity for raw material testing
Document test results, complete batch records, document observations and generate reports for raw material and in-process finished goods subassembly qualification testing
Responsible for generating compliant QC documentation as part of the Device Master Record required for releasing items into inventory from the raw material to the final kit assembly level
Maintain records and QC laboratory environment to comply with cGMP, SOP and regulatory requirements.
Serve as a contact for other departments regarding QC related activities, quality issues, nonconformance investigations, and root cause analysis
Provide input for brainstorming activities, support approaches for problem-solving, trouble-shooting and data analysis related to QC failures
Provide training to quality control team members
Assist in reagent and lab supply inventory management in order to support multiple QC laboratories
Coordinate/plan weekly QC activities with team in order to meet production demands
Review purchase orders for raw materials
Assist in the development and implementation of raw material testing processes, physical quality specification tests and documentation
Assist in performing routine maintenance of laboratory equipment
Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment
Assist in identifying quality gaps and support continuous improvement / operational excellence initiatives.
Assist in process monitoring and trending across all shifts.
Collect, interpret and communicate process metrics; utilize metrics to recommend improvements.
Support 5S efforts to streamline overall operations and improve efficiency
Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
Troubleshoot and investigate complex problems, work with others to implement solutions.
Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture in which no one gets hurt.
Supplementary Responsibilities
Assist in regular laboratory environment monitoring tests
Assist in transferring processes from development to QC
Assist in testing raw materials for reliability and stability
Assist in reagent manufacturing activities unrelated to QC activities
Education and Experience
Degree in Life Sciences (BA/BS in Biochemistry or Molecular Biology preferred) and a minimum of 5 years hands on experience in quality control or equivalent, or Associate degree and 5-7 years experience, or High School and 9 years experience.
Biotech (biochemistry experience) certificate from approved program and a minimum of 5 years hands-on experience
Knowledge, Skills and Abilities
Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving testing, investigations and theory.
Ability to lead department and/or cross functional meetings or projects.
Strong data-analysis skills, with clear demonstrated understanding of analytical, troubleshooting, and problem solving skills.
Hands on experience in a laboratory
Accurate and precise manual pipetting and measuring techniques
Experience working in a GLP, cGMP or ISO regulated environment is preferred, but not required
Experience with 5S and Lean techniques is preferred, but not required
Proven math skills
Experience with Excel and proficient understanding of Excel statistical formulas is preferred, but not required
Demonstrated attention to detail and strong organizational skills
Proven ability to meet deadlines and work under aggressive timelines
Demonstrated ability to work effectively in a team environment
Experience working with Tecan instruments or liquid handling systems is preferred, but not required
Experience with handling corrosive and biohazardous reagents is preferred, but not required
Work Environment/Physical Demands/Safety Considerations
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 requires gowning, hair net, safety glasses, gloves and foot coverings. May work with hazardous materials and chemicals.