Senior Research Quality Analytics Specialist
Posted on: May 3, 2021
Invitae is dedicated to bringing comprehensive genetic
information into mainstream medicine to improve healthcare for
billions of people. Our team is driven to make a difference for the
patients we serve. We are leading the transformation of the
genetics industry by making genetic testing affordable and
accessible for everyone to guide health decisions across all stages
The Senior Quality Analytics Specialist will lead diverse
cross-functional teams in the pursuit of quality analytical
services in compliance with appropriate regulations such as GMP
(good manufacturing practice), GLP (good laboratory practice), and
GCP (good clinical practice). Areas of direct influence will
include, but not be limited to, quality control testing, test
method validation, tech transfer, process validation, continual
process improvement, product stability program design and
execution, laboratory management, product specifications, and risk
assessments. This role shall provide strategic leadership to
establish and maintain quality levels that consistently deliver
best-in-class products that comply with US FDA Regulations, as well
as Regulations of OUS markets and manufacturing sites.
- Identify and lead continuous process improvement initiatives
that improve the customer experience, enhance workflow, business
and manufacturing processes and/or improve the work
- Liaise with early discovery and development partners to drive
the continuous flow of knowledge from manufacturing to early
research speeding development and reducing time to market for new
- Organize and oversee management of Quality principles for SPC,
Quality-by-Design (QBD), Quality Control, Test Method and Process
Validation, Tech Transfer and stability teams, including the review
and approval of protocols and reports.
- Foster a strong QBD culture striving for continuous quality
improvement throughout the entire company.
- Engage in driving the quantitative assessment of specification
setting, release limits, process monitoring metrics, and risk
- Provide strategic analytical leadership throughout the product
development process and ensure strong quality domain representation
in product development and manufacturing services teams
- In conjunction with cross functional leaderships develop
appropriate metrics, and tools for data collation.
- Oversee investigations of laboratory issues to insure timely,
closed loop corrective actions and reports as required through
- Lead by example to create an inclusive culture that values high
engagement driven to continuous improvement.
- Participate in the development of education and training
programs for quality initiatives, such as quality-by-design (QBD),
utilization of Design-of-Experiments (DOEs), SPC and quality
- Passion for enhancing healthcare outcomes with novel
- Problem solver, comfortable operating in the grey-space and
driving forward with risk balanced decision making.
- History of thriving in a fast-paced, dynamic environment.
- Inspirational team player with a passion for science and
driving to solutions.
- Driven to perform
- Self-directed, curious, and motivated to understand the
business, technical, scientific and regulatory aspects of the
- Able to organize and prioritize
- Strong leadership and communication skills
- Minimum of 5-10 years experience in two or more of the
following areas is required: quality, regulatory, laboratory
experience, statistics, six-sigma, engineering.
- Knowledge of biology, genetics, familiarity with genomic data,
proficiency in molecular techniques, NGS preferred.
- Working knowledge of cGMP/CFR/FDA regulations, with knowledge
of OUS regulations.
- Experience with applicable FDA regulations and ISO standards,
working knowledge of international regulations strongly
- A minimum of a master's degree in statistics, genetics, or
related field is required
- Advanced Degree preferred
In Colorado, our competitive compensation package includes a
base salary starting from $129,000 per year. In determining the
final salary offered, we will evaluate a specific candidate's
geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which
includes healthcare coverage, 401k, and a broad range of other
benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and
basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health
and wellness supports
At Invitae, we value diversity and provide equal employment
opportunities (EEO) to all employees and applicants without regard
to race, color, religion, national origin, gender, sexual
orientation, age, marital status, veteran status, or disability
status. We will consider for employment qualified applicants with
criminal histories in a manner consistent with the requirements of
the San Francisco Fair Chance Ordinance.
Keywords: Invitae, Boulder , Senior Research Quality Analytics Specialist, Other , Boulder, Colorado
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