Group Leader, Quality Control Environmental Monitoring
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: October 10, 2021
Supervise and be responsible for
day-to-day operations of environmental monitoring program and
ensuring all environmental monitoring is performed in accordance
with cGMP, regulatory guidelines, local and corporate procedures,
and Company Quality and Compliance Guidelines. Responsible for
managing monitoring, trending, investigation processes and
departmental personnel. Ensures that non-conformity
investigations are thorough and timely to support business
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 employees.
- Responsible for ensuring environmental monitoring
is performed within regulatory/compliance
- Responsible for trending results of, improving
(reducing, refining, replacing, or eliminating) and providing
technical support for bio-analytical methods or compliance/support
functions within regulatory/compliance
- Responsible for the maintenance of a clean, safe,
orderly and compliant lab or compliant compliance/support
- Responsible for assuring TOC monitoring of
process waters are tested and reported in an accurate and timely
- Responsible for keeping updated with
product-relevant literature, implementing new/emerging technology
and supervising scientists and lab specialists/technicians.
Responsible for test schedules, training curricula, operational
budget, capital budget, lab and office space, and employee
development and evaluation.
- Familiar with Outlines of Production, Special
Outlines, Supplemental Assay Methods, and US, European and Japanese
- Responsible for reporting data using appropriate
regulatory forms, generating/maintaining assay-relevant databases,
generating assigned reports and carrying out assigned
- Perform Company business in accordance with all
regulations and Company policies and procedures. Demonstrate
high ethical and professional standards.
- Bachelor's Degree in related business or
scientific field from an accredited institution.
- In addition to Bachelor's degree, a minimum four
(4) years of experience in cGMP Aseptic production, Bio
manufacturing, pharmaceutical or similar manufacturing
environment. Experience must be inclusive at least three (3)
years leading people and/or moderate to complex process improvement
and related production projects.
- Experience must be inclusive of managing and
auditing master receipts, batch records and process order data
within relevant SAP/ERP software systems.
- Experience in ERP inventory control system(s)is
preferred but not necessary.
- Experience with word processing, spreadsheets,
and database management required.
- Demonstrated ability to train others and complete
- Demonstrates the ability to follow systematic
continuous improvement methodologies and the willingness to
identify, define, and implement process
- Demonstrated knowledge of Aseptic or related
production techniques and equipment.
- A working knowledge of cGMP, EU and OSHA Part 11
guidelines as they pertain to implementing process improvements on
aseptic production or other production
- Must be detail oriented, able to work with
minimal supervision and self-motivated to utilize resources to
troubleshoot as needed.
- Ability to manage multiple on-going projects with
- Strong proofreading skills along with excellent
communication and written capabilities.
- Must be proficient in MS office applications such
as Word, Excel, Outlook, etc.
- Must be able to readily learn and quickly become
proficient in all software applications utilized for packaging
equipment and operations.
- 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 , Group Leader, Quality Control Environmental Monitoring, Other , Saint Joseph, Missouri
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