We’re in search of a Senior
Quality Assurance Specialist to work on innovative aesthetic,
therapeutic and financial technology offerings, setting a new standard in
healthcare. With experience in technical writing and authoring of quality
system records such as laboratory investigations, deviations, CAPA, and change
controls pertaining to operational functions supported by Quality Systems &
Compliance (e.g., Quality Control)
Here are some of the specific details:
Job
Title: Quality Assurance Specialist IV
Location: Newark, CA
Duration: 06 Months contract (with possibility of
extension)
Status: Onsite
Job Description:
Summary:
Client is a commercial stage biotechnology
company focused on innovative aesthetic, therapeutic and financial technology
offerings, setting a new standard in healthcare. The Specialist IV provides
compliance support or oversight for operational functions at Client. This
includes technical writing and authoring of quality system records such as
laboratory investigations, deviations, CAPA, and change controls pertaining to
operational functions supported by Quality Systems & Compliance (e.g.,
Quality Control). Conducts investigations for Laboratory Investigation Reports
(LIR) and deviations via effective root cause analysis. Monitors completion of
the quality system records and provides escalation to management, as needed.
Generates and analyzes metrics for operational activities, including but not
limited to laboratory investigations and invalid assays and other laboratory
operation parameters as appropriate. Authors and/or revises other controlled
documents such as procedures, methods, work instructions, protocols, and
reports as applicable. Ensures personnel compliance of corresponding training
programs for supported operational functions.
- Provide
technical writing in support of operational functions, such as Quality
Control (QC).
- Responsible
for authoring Out of Specification (OOS) and anomalous event laboratory
investigations, deviations, CAPA, and change controls.
- Perform
risk analysis as needed to determine severity, likelihood of recurrence
when triaging events and/or conducting investigations.
- Conduct
investigations thoroughly for OOS events according to the phase-based
approach per FDA and Annex guidelines.
- Investigate
deviations to identify root cause and contributing factors and in parallel
assess impact to patients, product quality, data integrity, validated
state, and regulatory compliance.
- Identify
and develop relevant and effective CAPA.
- Address
impact to systems, processes, product, and any regulatory requirements
when authoring change controls.
- Prioritize
and monitor completion of lab investigations, deviations, CAPA, and change
controls.
- Maintain
expected standards with concise technical writing using correct grammar,
detailed and accurate information, to be completed within established
timelines.
- Generate
and analyze metrics as applicable.
- Manage
and author change controls related to qualification, modification, and/or
decommissioning of equipment.
- Possess
a strong understanding of data integrity principles.
- Ensure
compliance of personnel with corresponding training program(s).
WORK ENVIRONMENT and PHSYICAL DEMANDS:
- This
section of the job description is required by the American with Disability
Act, (ADA). The ADA requires that job descriptions reflect the physical
and mental demands required to effectively perform the essential duties of
the job. The ADA prohibits employers from discriminating against a
“qualified individual with a disability” in all aspects of the employment
relationship. A “qualified individual with a disability” is “an individual
who meets the education, experience, skill, and other job-related requirements
of a position held or desired, and who, with reasonable accommodation, can
perform the essential functions of a specified job.”
- Prolonged
periods of sitting at a desk and working on a computer.
- Must
be able to lift up to 10 pounds at times.
We are an equal opportunity employer. We are a
company where diverse backgrounds, experiences and viewpoints are valued.
Client does not discriminate in practices or employment opportunities on the
basis of an individual's race, color, national or ethnic origin, religion, age,
sex, gender, sexual orientation, marital status, veteran status, disability, or
any other prohibited category set forth in federal or state regulations.
Skills: EXPERIENCE:
- A
minimum of 3 years work experience within a GMP environment working with
small and/or large molecules.
- Experience
with a wide range of analytical techniques such as ELISA, SDS-PAGE,
Western Blot, Karl Fischer, UV and HPLC (Waters Empower software is
preferred), and Relative Potency Assay.
- Solid
technical training and troubleshooting experience are essential.
- Strong
understanding of data integrity principles within a GMP environment is
required.
PREFERRED ADDITIONAL SKILLS (I.E.,
COMPUTER):
- Expertise
in use of Microsoft Office applications.
Keywords:
Education:
- Bachelor's
in biology, biochemistry or related pharmaceutical-biotechnology
discipline is required.
Skills and Experience:
Required Skills:
- DISABILITY
- BIOTECHNOLOGY
- QUALITY
SYSTEM
- WESTERN
BLOT
- LABORATORY
Additional Skills:
- GMP
- QUALITY
ASSURANCE
- ELISA
- QUALITY
CONTROL
- ROOT
CAUSE ANALYSIS
- FDA
- DATA
INTEGRITY
- THERAPEUTIC
- MICROSOFT
OFFICE
- BIOCHEMISTRY
- TRAINING
PROGRAMS
- METRICS
- RISK
ANALYSIS
- CORRECTIVE
AND PREVENTIVE ACTION
- HPLC
- REGULATORY
COMPLIANCE
Minimum Degree Required: Bachelor's Degree
Certifications & Licenses:
CAPA
Let me know if you are interested in this job
and/or if you can assist us by referring someone who is interested in this job,
since we offer the lucrative referral bonuses.
A reasonable, good faith estimate of the
minimum and maximum for this position is $60-$65/hour
Benefits will also be
available and details are available at the following link: Harvey
Nash Benefits
I am looking forward to speaking with you
today.
About us:
Harvey Nash is a national, full-service talent
management firm specializing in technology positions. Our company was founded
with a mission to serve as the talent partner of choice for the information
technology industry.
Our company vision has led us to incredible
growth and success in a relatively short period of time and continues to guide
us today. We are committed to operating with the highest possible standards of
honesty, integrity, and a passionate commitment to our clients, consultants,
and employees.
We are part of Nash Squared Group, a global
professional services organization with over forty offices worldwide.
For more information, please visit us at https://www.harveynashusa.com/
Thanks & Regards,
Raj
Kumar. Ch
Sr. IT Recruiter
(732) 279-4244
Raj.kumar@harveynash.com