GMP Auditor - Remote
Intertek, a leading provider of quality and safety solutions to many of the
world’s top-recognized brands and companies, is actively seeking a Pharma,
Dietary Supplement and Cosmetic GMP Auditor to join our Remote Business
Assurance team. This is a fantastic opportunity to grow a versatile career in
GMP Auditing
Intertek's Business Assurance team goes beyond testing, inspection and
certification to look at the underlying elements that make a company and its
products successful. Our assurance solutions provide confidence and total peace
of mind that a client's operating procedures, systems and people are functioning
properly to provide a competitive advantage in the marketplace. Intertek is
continually innovating and evolving to reduce risk for consumers, brands and
organizations in every sector and industry around the world. We go beyond
Testing, Inspection and Certification of products: we are a Total Quality
Assurance Provider to industries worldwide. Our Purpose: Bringing quality,
safety, and sustainability to life.
What are we looking for?
This is a full-time position, with the person primarily responsible for
performing GMP compliance supplier audits to assure that client’s products have
been manufactured, tested, handled and stored in compliance with applicable FDA
or other country specific regulations and client specific requirements. This
position will travel at least 50% to 75% of the time.
Salary & Benefits Information
Individual compensation packages are based on a variety of factors unique to
each candidate including skill set, experience, qualifications, and other
job-related reasons.
In addition to competitive compensation packages, when working with Intertek you
can expect benefits including medical, dental, vision, life, disability, 401(k)
with company match, generous vacation / sick time (PTO), tuition reimbursement
and more.
What you’ll do:
Plan, prepare, and conduct of facility audits in support of GMP as directed.
Create Audit Plans and Agendas, and send to site;
Hold Opening and Closing Meetings;
Interview and observe operations in situ.
Assemble and coordinate the activities of the audit team.
Interpret policies, standards, and regulations, and then evaluates
potentially critical problems not covered by policies, standards, and
regulations.
Assess compliance with applicable FDA, or country specific regulations and
guidelines, and/or the client’s requirements and specifications.
Advise office immediately of any critical observations identified during
audit.
Ensure that written procedures are followed, and exercise judgment in
evaluating quality systems, processes, procedures, and protocols for
compliance.
Review SOPs to ensure procedures and systems used in the regulated processes,
such as manufacturing and testing, are in compliance with applicable
regulations and guidelines, including documented procedures for OOS, recalls,
deviations, complaints, CAPA, QA responsibilities, batch record review and
batch disposition.
Appropriately escalate any compliance issues.
Communicate audit results to management and auditees through written audit
reports.
Draft and Submit Audit Report for internal review.
Manage post-audit activities (e.g.: CAPA assessment and review) and follow up
on any necessary corrective and preventive actions by resolving any
conflicts.
Manage and ensure all travel arrangements are in compliance with applicable
travel policies.
Maintain current knowledge of industry standards and expectations.
This position outline is a general guideline and does not represent all
encompassing details. The position assumes that the incumbent has both the
mental and physical requirements to carry out the above defined duties.
Minimum Requirements & Qualifications:
Accredited Quality Auditor Certification through ASQ, ANAB, IRCA or other
recognized auditor training body meeting ISO/IEC 17021 (for management system
certification bodies) or ISO/IEC 17065 (for product/process certification
bodies).
A four-year college/university degree in a science or technical field
(biology or microbiology; chemistry or biochemistry; computer and software
technology; electrical, electronic, mechanical or bioengineering; human
physiology; medicine; pharmacy; physics or biophysics) or equivalent
combination of relevant education and work experience.
Minimum of two-years experience in GMP industry environment (Manufacturing,
CAPA, Auditing, Complaint Review)
Valid driver’s license and reliable driving record is required.
Routine demands of an office-based environment.
This is a remote position; however, applicants must reside in and be able to
legally work in the United States.
Preferred Requirements & Qualifications:
A minimum of 5 years actively participating in a GMP lead auditor role;
supplier auditing experience
Previous project management experience working in an ATIC environment is an
advantage.
PHYSICAL REQUIREMENTS:
This role requires the ability to:
Ascend or descend ladders, stairs, ramps, and the like, using feet and legs
and/or hands and arms. Body agility is emphasized.
Stand, for sustained periods of time.
Walk, moving on foot to accomplish tasks and to move from one work location
to another.
Communicate well, thru spoken word, conveying detailed accurate information &
instructions to others.
Hear well, perceiving sounds with or without correction, including the
ability to receive information thru oral communications.
Exert up to 10 pounds of force occasionally and/or negligible amounts of
force frequently to lift, carry, push, pull or otherwise move objects.
Have close visual acuity to perform an activity such as preparing & analyzing
data, viewing a computer monitor, reading, report writing, visual inspection,
and use of measurement devises.
Intertek: Total Quality. Assured.
Intertek is a world leader in the Quality Assurance market, with a proven,
high-quality business model and a global network of customer-focused operations
and highly engaged subject matter experts. With passion, pace, and precision we
work to exceed our customers’ expectations, while engaging with our employees to
be 10X in their performance and professional growth.
Intertek is a drug-free workplace. As a condition of employment, certain
positions may be required to pass a pre-employment drug test based on the type
of work that will be performed.
We Value Diversity
Intertek’s network of phenomenal people are our greatest assets, and the
diversity they bring fuels our success. Intertek is an Equal Employment
Opportunity Employer that values inclusion and diversity. We take affirmative
action to ensure all qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, veteran status, or other legally
protected characteristics.
For individuals with disabilities who would like to request accommodation, or
who need assistance applying, please email intertekhrusa@intertek.com or call
1-877-694-8543 (option #5) to speak with a member of the HR Department.
#LI-JC1
#LI-REMOTE
Intertek is a leading Total Quality Assurance provider to industries worldwide.
Our network of more than 1,000 laboratories and offices in more than 100
countries, delivers innovative and bespoke Assurance, Testing, Inspection and
Certification (ATIC) solutions for our customers' operations and supply chains.
Working at Intertek means joining a global network of state-of-the-art
facilities and passionate people who deliver superior customer service with a
purpose of bringing quality, safety, and sustainability to life.
The Business Assurance group of Intertek provides a full range of business
process audit and support services, including management systems certification,
sustainability and responsible sourcing audits, risk management, and training.
Our range of bespoke auditing, performance benchmarking and supply chain
solutions provide insight into every aspect of operations, allowing clients to
make informed decisions about their business while ensuring their workforce
competencies are current and relevant.