Senior QC Engineer
Company: Illumina, Inc.
Location: california hot springs
Posted on: May 3, 2021
We are looking for a driven and talented Senior QC Engineer to
join our QC Technical Operations (QCTO) group supporting Reagent
Quality Control. This team provides technical expertise to the
Reagent QC manufacturing team in the areas of assay transfer,
implementation, and troubleshooting, technical product performance
investigations, process improvement, and collaboration with the
manufacturing team to implement strategic initiatives. The
candidate must be able to deliver multiple programs in parallel and
under aggressive timelines.This position will be a key business
partner in managing the quality and manufacturing relationship,
which includes auditing, guidance on gap/risk closure, and meeting
business and regulatory obligations with a high degree of
integrity. The ideal candidate will have experience with and
knowledge of Illumina Assays and sequencing technology.
- Promote and execute quality standards, inspection processes,
test methodology, quality plans, documents and reports.
- Devises sampling procedures and designs and develops forms and
instructions for recording, evaluating, and reporting quality and
- Perform routine and non-routine inspection/characterization to
support release, and QC testing of raw materials, production
intermediates and final goods.
- Identify and drive the development and implementation of
activities/methods to improve first pass yield to support
- Developing and validating testing methodology. Setup, revising
and updating Standard Operating Procedures, system or processes to
improve material/process specifications/test methodology.
- Constantly review procedures and processes and work closely
with key internal partners to provide recommendations for
- Develop procedures, work instructions, guidance, best practice
protocol such as checklists and troubleshooting guidelines.
- Compiles and writes training material and conducts training
sessions on quality control activities.
- May perform troubleshooting on discrepancy observed in
laboratory or material as necessary.
- Ensure that the lab processes are compliant with Quality System
and EHS requirements.
- Assignments include areas such as leading product transfer,
troubleshooting, nonconformance evaluation, product release
improvement, complaint handling investigations, CAPA, material
control, process & system enhancement and drive sustaining
activities to meet QC goals, etc
- Assignment may include but not limited to evaluation of
non-conformance material, method improvement to incoming and
outgoing inspection, calibration, analytical or bio-molecular QC
assays to support release, characterization and stability testing
of raw materials, production intermediates and final goods
- Work in accordance with procedures and integrated program plans
for achieving and maintaining the required level of product quality
in preparation for FDA and ISO third party audits.
- Works on problems of diverse scope where analysis of data
requires review and interpretation of identifiable factors.
- Demonstrates solid judgment in selecting methods and techniques
for obtaining solutions.
- May provides leadership and mentor junior staff to resolve
- Other such duties that may be determined by Management.
Listed responsibilities are an essential, but not exhaustive list,
of the usual duties associated with the position. Changes to
individual responsibilities may occur due to business needs.
- Experience with QC processes and application of various
biochemical assays or analytical tools. Experience with Illumina
assays or similar DNA library preparation and sequencing technology
- Good understanding of FDA regulatory environment (CFR 820),
501k and ISO 13485 strongly preferred.
- Experience in supporting manufacturing operations, or QC/QA
operations. Individual with CQE is a plus.
- Experience with data mining, trend analysis, control charting,
- May have experience with leading method development/ NPI
transfer projects independently
- Ability to apply experience in meeting requirement of FDA
Quality /System Regulations and/ or ISO 13485 Standard.
- Able to interpret engineering drawing for mechanical commodity
- hardware, metal and plastic parts.
- Effective failure investigation, technical report writing, data
mining, trend analysis, statistical analysis.
- Intermediate to advanced experience with words processing and
spreadsheets, charting, graphing tools and presentation tools.
- May have experience with electronic production life (PLM),
enterprise resource planning tools (SAP) and etc.. May have
experience with statistical analysis packages, eg, JMP,
- Intermediate to advanced level of knowledge in GD&T, QC
Tool, FMEA, Cpk, Gauge R&R.
- Ability to design and deliver training to others with regard to
work processes and/or quality system elements.
All listed requirements are deemed as essential functions to this
position; however, business conditions may require reasonable
accommodations for additional task and responsibilities.
- MS degree with at least 3 years of related experience, or BS
degree with at least 5 years of related experience
- Field of study in Organic Chemistry, Chemistry, Molecular
Biology, Biochemistry, Chemical Engineering, Biochemical
Engineering or similar discipline preferred
At Illumina, we strive to foster a diverse and inclusive workplace
by cultivating an environment in which everyone contributes to our
mission. Built on a strong foundation, Illumina has always been
rooted in openness, collaboration, and seeking alternative views
and perspectives to propel innovation in genomics. We are proud to
confirm a zero-net gap in pay, regardless of gender, ethnicity, or
race. We also have several Employee Resource Groups (ERG) that
deliver career development experiences, increase cultural
awareness, and demonstrate our collective commitment to diversity
and inclusion in the communities we live and work. We are proud to
be an equal opportunity employer committed to providing employment
opportunity regardless of sex, race, creed, color, gender,
religion, marital status, domestic partner status, age, national
origin or ancestry, physical or mental disability, medical
condition, sexual orientation, pregnancy, military or veteran
status, citizenship status, and genetic information. If you require
accommodation to complete the application or interview process,
please contact email@example.com. To learn more, visit:
Keywords: Illumina, Inc., Bakersfield , Senior QC Engineer, Other , california hot springs, California
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