QC Scientist

Roche - San Jose, CA4.2

Full-time
Summary
The Scientist, Quality Control – Reagent Manufacturing will be an integral part of a Operations 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
  • 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 in a timely and
efficient manner
  • Ensure Training is always up to date and support training others as needed
  • 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
 May assist in regular laboratory environment monitoring tests
 May assist in transferring processes from development to QC
 May assist in testing raw materials for reliability and stability
 May 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 3-5
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 3-5 years handson
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 cross functional meetings or projects is preferred, but not required.
 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.

Who we are
At Roche, 94,000 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.

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.