Quality Control Specialist (Palo Alto, CA)
Company: Kelly Services
Posted on: April 9, 2021
Quality Control Specialist II (Palo Alto, CA)Direct Hire--This
laboratory is seeking--a quality control specialist to--design,
develop, evaluate and implement quality control testing, assays and
procedures for clinical materials manufacturing consistent with
principles of current Good Manufacturing Practice cGMP to support
phase appropriate clinical investigations for treating patients
with incurable diseases. This working site is a GMP multi-product
biologics manufcturing facility tht provides regulatory, quality
systems, process development and manufacturing support to hospitals
and healthcare centers to develop innovative cell and gene-based
therapies for the treatment of disease and the promotion of health
in pediatric and adult patients in Phase I/II clinical trials.
Apply to join this purpose-driven team who is dedicated to support
translational medicine.--Duties include:
- Evaluate, develop and perform complex chemical, biochemical,
biological and/or microbiological testing, assays and procedures
related to quality control QC , which constitute the quality,
safety and efficacy of all analytical methods for clinical
- Develop and perform tests related to assays/analytical methods;
collect, interpret, analyze and report data related to test results
including investigation of out-of-specification and/or
non-conforming test results.
- Perform analytical method, analyze collected data, and
determine specifications for each test method.
- Evaluate proposed specification changes and escalate to
- Present data to stakeholders PIs,--team, clinical team .
- Perform and document assay qualification as applicable per
- Document execution of test methods according to test procedure,
GMP, and good documentation requirements.
- Manage materials/supplies related to clinical materials
- Create selection criteria, justification and qualification of
raw materials as it relates to assay development.
- Responsible for examining and documenting materials used in
clinical materials quality control testing, consistent with
defined, relevant quality standards and cGMP.
- Participate in the evaluation of suppliers/contract testing lab
including, but not limited to, analyzing test methods and
establishing contract with supplier/vendor as applicable.
- Resolve issues associated with vendor/supplier and
changes/deviations to the generation of materials/reagent.
- Ensure equipment qualification, preventive maintenance, and
calibration are performed per requirement and by due date.
- Coordinate equipment implementation for use and decommissioning
- Investigate out-of-specification and/or non-conforming test
- Initiate, investigate as appropriate, and prepare deviation
reports for SOPs and test methods with input from supervisor in
order to implement prevention or corrective actions.
- Perform QC Support tasks e.g. equipment maintenance, tracking
of reagent and sample inventory, organization of the lab, checking
to ensure removal of expired media performed, etc.
- Coordinate the timely shipment of samples to contract
laboratory for testing e.g. ship samples such as environmental
monitoring plates for growth promotion, speciation and product
- Other duties may also be assignedDESIRED QUALIFICATIONS:
- Ability to effectively work in fast pace environment with cross
functional groups involved in multiple projects
- Ability to effectively work in fast pace environment with cross
functional groups involved in multiple projects and timelines.
- Flexibility to support changing priorities while maintaining
collaborative approach and cGMP compliance.
- Able to work independently with some supervision, propose
recommendations and solutions regarding development and execution
of QC assays.
- 3-5 years cGMP experience.
- Experience with Cell Culture activities, Flow Cytometry, qPCR,
Sterility testing, and/or Environmental Monitoring
activities.EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in relevant scientific discipline or other
appropriate specialty (such as Chemistry, Life Sciences,
Biochemical Engineering, or Engineering) and three years'
experience or an equivalent combination of education and relevant
work experience.KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Applicable or related experience in clinical laboratory,
hematology, blood banking, immunology or QC laboratory preferably
in cGMP environment.
- Strong analytical technical skills and experience with testing
QC methods and concepts.
- Good understanding of cGMP or International Organization for
Standardization (ISO) requirements, quality systems.
- Strong team-oriented, interpersonal skills and collaborative
- Ability to manage and coordinate all tasks assigned and
effectively complete all expected deliverables in a timely manner
and proactively communicate changes in pre-established goals and
- Excellent organizational skills and attention to detail.
- Excellent verbal and written communication skills.--PHYSICAL
- Frequently sit, grasp lightly, use fine hand manipulation,
repetitive pipetting, perform desk-based computer tasks, and lift,
carry, push, and pull objects up to 15 pounds.WORKING CONDITIONS:
- May require working in close proximity to blood borne
- Position may at times require the employee to work with or be
in areas where hazardous materials and/or infectious diseases are
- Employee must perform tasks that require the use of personal
protective equipment, such as safety glasses and shoes, protective
clothing and gloves, and possibly a respirator.
- May be exposed to high voltage electricity, radiation or
electromagnetic fields, lasers, noise > 80dB TWA,
Allergens/Biohazards/Chemicals, confined spaces, working at
- May require extended or unusual work hours (including weekends)
based on research requirements and business needs.Why Kelly--?Kelly
Science & Clinical is your connection to premier scientific and
clinical companies looking to hire talented people just like you.
Every day, we match science professionals with dream jobs that fit
their skills and interests-it's the way we think job searching
should be. Nearly 100 percent of our science recruiters have a
professional background/education in science, so we know a thing or
two about the science market and how to get you noticed.About
Kelly--At Kelly, we're always thinking about what's next and
advising job seekers on new ways of working to reach their full
potential. In fact, we're a leading advocate for
temporary/nontraditional workstyles, because we believe they allow
flexibility and tremendous growth opportunities that enable a
better way to work and live. Connecting great people with great
companies is what we do best, and our employment opportunities span
a wide variety of workstyles, skill levels, and industries around
the world. Kelly is an equal opportunity employer committed to
employing a diverse workforce, including, but not limited to,
minorities, females, individuals with disabilities, protected
veterans, sexual orientation, gender identity. Equal Employment
Opportunity is The Law.]]
Keywords: Kelly Services, San Francisco , Quality Control Specialist (Palo Alto, CA), Other , Stanford, California
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