GCP QA Auditor II
Company: Thermo Fisher Scientific
Location: Waterbury
Posted on: August 7, 2022
Job Description:
PPD is a leading global contract research organization providing
comprehensive, integrated drug development, laboratory and
lifecycle management services.--- At PPD, we are passionate,
deliberate, and driven by our purpose- to improve health!------
-Envision a workplace where you have a direct impact on improving
health, work alongside expert scientists, use newest technologies
and collaborate with industry thought leaders and therapeutic
experts. Welcome to PPD - Laboratories, where science is our
passion, quality is our commitment and people are the cornerstone
of our success.--- -As QA Auditor II, you will work remotely and
travel to conduct -complex internal and external audits and
inspections to ensure compliance with established -quality
assurance processes, standards, global regulatory guidelines and
client contractual obligations. - -SUMMARIZED PURPOSE:Conducts
complex internal and/or external audits and inspections to ensure
compliance with established -quality assurance processes,
standards, global regulatory guidelines and/or client contractual
obligations. -Identifies issues impacting the quality and/or
integrity of clinical research programs, determines root -cause of
non-conformance and develops strategies to address issues. May
perform technical document -review and other -GxP -practice
activities in support of clinical development programs. Provides
audit -reports to management. Plans and delivers quality services
for contracted quality assurance audits, -internal site audits,
laboratory and file audits for clients and projects. -ESSENTIAL
FUNCTIONS:
- Conducts and/or leads a variety of client, internal or -GxP
-audits and regulatory -inspections as requested by senior
management
- Leads directed site audits, facility, vendor and/or
sub-contractor audits -
- Provides -GxP -consultation and support to PPD project teams
and external clients -Leads process audits and may participate as a
co-auditor in more complex -system audit.
- Performs other types of QA audits or activities (e.g. database
audits, clinical -study report audits, sample results tables,
process improvement) -
- Serves as a resource to operational departments on audit or
quality assurance -subject matter -
- Prepares and presents audit findings and/or other related
information at -departmental, internal operations or client
meetings -
- Provides mentorship and guidance to junior auditors -At PPD we
hire the best, develop ourselves and each other, and recognize the
power of being one team. We offer continued career advancement
opportunities, award winning training and benefits focused on the
health and well being of our employees.------ -EDUCATION AND
EXPERIENCE:
- Bachelor's degree or equivalent and relevant formal academic /
vocational qualification -
- Previous QA experience that provides the knowledge, skills, and
abilities to perform the job (comparable to at least 2+ years) or
equivalent combination of education, training, & experience.
Successful completion of PPD Foundation Training. -KNOWLEDGE,
SKILLS AND ABILITIES:
- Meets competencies for QA Auditor I plus:
- Thorough knowledge of -GxP -and appropriate regional research
regulations and guidelines -
- Demonstrated proficiency and led a range of project based or
internal -GxP -audits and vendor audits to high standards required
by management -
- Excellent oral and written communication skills -
- Strong problem solving, risk assessment and impact analysis
abilities -
- Solid experience in root cause analysis -
- Above average negotiation and conflict management skills -
- Flexible and able to multi-task and prioritize competing
demands/workload -
- Valid driver's license and ability to qualify for and maintain
a corporate credit card with sufficient credit line for business
travel--- -
- Knowledge of 21 CFR 11 compliance is a big plus
- French as a 2nd language is a plusWORKING ENVIRONMENT:PPD
values the health and wellbeing of our employees. We support and
encourage individuals to create a healthy and balanced environment
where they can thrive. -Below is listed the working
environment/requirements for this role: -
- Able to communicate, receive, and understand information and
ideas with diverse groups of people in a comprehensible and
reasonable manner. -
- Able to work upright and stationary for typical working hours.
-
- Ability to use and learn standard office equipment and
technology with proficiency. -
- Able to perform successfully under pressure while prioritizing
and handling multiple projects or activities. -
- Up to 50% travel - (Approximately 2 audits per month) - -
- Employees hired in this role may be assigned to a US government
contract and if so would be subject to COVID-19 vaccination and
reporting requirementsPPD DEFINING PRINCIPLES:We have a strong will
to win - We earn our customer's trust - We are game changers - We
do the right thing ----We are one PPD------ -If you resonate with
our five principles above, and ultimately wish to accelerate the
delivery of safe and effective therapeutics for some of the world's
most urgent health needs, then please submit your application -
we'd love to hear from you.------ -PPD is an equal opportunity
employer.
Keywords: Thermo Fisher Scientific, Waterbury , GCP QA Auditor II, Accounting, Auditing , Waterbury, Connecticut
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