Principal Specialist, QA Auditing (Remote)
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: July 19, 2021
Leads and conducts external audits to assess the
quality / compliance of current Good Manufacturing Practice (cGMP),
applicable regulations, and applicable company policies and
procedures of external suppliers and contractors on behalf of the
BIV-US facilities and external suppliers and contractors on behalf
of the BI manufacturing world, including Operations, Development,
Biopharma, and Animal Health. Ensures corrective measures are
implemented. Provides transparency of risks from non-compliance.
Assesses the implementation and execution of quality / GMP
standards at suppliers and contractors to meet FDA/EU and other
relevant regulatory requirements, and to prevent and mitigate
As an employee of Boehringer Ingelheim, you will
actively contribute to the discovery, development and delivery of
our products to our patients and customers. Our global presence
provides opportunity for all employees to collaborate
internationally, offering visibility and opportunity to directly
contribute to the companies' success. We realize that our strength
and competitive advantage lie with our people. We support our
employees in a number of ways to foster a healthy working
environment, meaningful work, diversity and inclusion, mobility,
networking and work-life balance. Our competitive compensation and
benefit programs reflect Boehringer Ingelheim's high regard for our
- Schedule, plan, and prepare for external supplier
and contractor audits on behalf of BI pharmaceutical world
functions, including Operations, Development, Biopharma and Animal
Health, as well as internal audits of BIAH and other BI operating
units Operations, Development, Biopharma and Animal Health
- Lead and conduct audits of external suppliers and
contractors on behalf of the BIAH-US facilities and external
suppliers and contractors on behalf of the BI manufacturing world,
including Operations, Development, Biopharma, and Animal Health.
Prioritize and self manage audit and inspection
- Create and issue the audit report for each audit
to submit to BIAH management as a means to ensure SOP(s),
facilities, systems, processes and studies conform to applicable
cGMP, Good Laboratory Practices (FDA, USDA, EU), Good Clinical
Practices (FDA), and/or Guidance Documents (FDA, USDA, EU)
internally and for external
- Perform follow-up actions and oversee
investigations of compliance issues noted during audits and
inspections or otherwise observed or reported.
- Perform follow-up actions, including over-site of
compliance issues noted during audits and inspections or otherwise
observed or reported. Plan, perform, document, and conduct required
post-audit activities for assigned internal and external audits to
ensure timely closure of CAPAs. Communicate deviations from the
cGMP or other Regulations observed during audits/inspections,
recommend appropriate corrective action when necessary, and verify
that appropriate corrective actions have been implemented that
adequately address any deviations reported during audits to BI
- Resolve quality concerns and implement quality
improvements by meeting with other department Managers, Staff
Managers to assure current methods, procedures or SOP’s meet
current standards. Develop, review and/or approve documents
associated with Supplier Quality Management (e.g., change controls,
specifications, compliance certificates, etc.).
- Mentor and train other BI auditors regarding
auditing skills, and current and future quality and regulatory
trends as part of BI global supplier auditor training. Serve
as the subject matter expert to suppliers on compliance topics for
BIVI. Acts as a resource for colleagues (especially USA and
EU)regarding Good Manufacturing Practice (GMP) for APIs, excipients
and Good Distribution Practice, and pharmaceutical products
- Enable global quality overview of BI suppliers,
challenge their status and identify gaps/risks for BI's Supply
- Requires a Bachelor's Degree from an accredited
institution in Industrial Engineering, Biology, Chemistry or other
- Requires a Minimum of eight (8) years of
progressive experience in comparable quality or auditing function
in a GMP regulated environment.
- Requires a Quality Engineer / Auditor
certification from ASQ or equivalent and qualification as a Lead
- One to three (1-3) years of experience leading
- Advanced/in-depth knowledge of relevant
regulations and guidances as well as understanding of scientific
methods and processes used to manufacture, test, evaluate and
distribute biological and pharmaceutical
- In-depth knowledge of Quality Systems and related
norms (e.g. ICH 8/9/10, ISO 9000 series) and cGMP regulations and
related practices required.
- Willing and able to travel at least 70% of the
- Works independently with minimal guidance. Must
possess demonstrated organizational skills that have proven results
in the ability to be self-directed. Strong independent
judgement and decision making abilities
- Excellent analytical skills.
- Excellent conflict resolution and negotiation
skills, excellent verbal and written communication skills and the
ability to conduct respectful interactions with individuals with
diverse views or backgrounds
- Ability for work in cross-functional teams and
with international alignment.
- Knowledge of process improvement concepts and
applications in compliance environment.
- Required the capability to work with
international business partners with intercultural
- Skillful in using office application software
(MS-Word, MS-Excel, MS-Outlook).
- Ability for work in cross-functional teams and
with international alignment.
- Physical Demands /
- Lifting – 25 pounds
- Carrying 25 pounds
- May require extended periods of sitting, walking
- Climb stairs, bending/stooping,
- Writing frequently
- May have periods of use of Personal Protective
- Visual / Hearing Demands\: Contact
lenses are allowable. May require extended hours at a computer
screen. Must be able to read electronic documents of all
- Must be legally authorized to work in the United
States without restriction.
- Must be willing to take a drug test and
post-offer physical (if required).
- Must be 18 years of age or
Who We Are\:
At Boehringer Ingelheim we create value through
innovation with one clear goal\: to improve the lives of patients.
We develop breakthrough therapies and innovative healthcare
solutions in areas of unmet medical need for both humans and
animals. As a family owned company we focus on long term
performance. We are powered by 50.000 employees globally who
nurture a diverse, collaborative and inclusive
culture. Learning and development for all employees is key
because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com
and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global
employer who takes pride in maintaining a diverse and inclusive
culture. We embrace diversity of perspectives and strive for an
inclusive environment, which benefits our employees, patients and
communities. All qualified applicants will receive consideration
for employment without regard to a person’s actual or perceived
race, including natural hairstyles, hair texture and protective
hairstyles; color; creed; religion; national origin; age; ancestry;
citizenship status, marital status; gender, gender identity or
expression; sexual orientation, mental, physical or intellectual
disability, veteran status; pregnancy, childbirth or related
medical condition; genetic information (including the refusal to
submit to genetic testing) or any other class or characteristic
protected by applicable law.
Keywords: Boehringer Ingelheim, Saint Joseph , Principal Specialist, QA Auditing (Remote), Other , Saint Joseph, Missouri
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