Scientist III, Microbiology Quality Control
Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: October 15, 2021
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Job Description:
Description: Description\: The Bio Quality Control group is responsible for performing
bio-analytical methods (immunological, in vivo, microbiological,
molecular biological, or virological) for various Bio QC tests on
raw materials, in-process, release or stability samples in
compliance with 9CFR, EU and VICH regulatory guidelines, Outlines
of Production and Special Outlines. The incumbent will
initiate, execute and complete assays as per validated procedures
and within Quality and Compliance guidelines. The incumbent
is responsible for timely communication with supervisors to inform
them of testing, compliance and/or scheduling issues, adhering to
company policies, maintaining a safe work environment through Site
safety KPIs, living out the Lead & Learn principles and following
appropriate GMP documentation. Additional duties are based up
the incumbents level. 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
employees. Duties & Responsibilities Testing Perform testing using a portion of the existing laboratory
assays Perform testing using a significant portion of the existing
laboratory assays Maintains laboratory reagents, supplies and calibrated
equipment Prepare reagents and materials Calculates results Communicates schedule, test status and concerns Write Laboratory Investigations, as needed. Review and approve results and test sheets Revise a Pre-existing Standard Methods and SOPs Create New Standard Methods, SOPs, Protocols Trains others on methods & procedures Support Plans activities and structures work for others Prepares work schedule for self Uses data analysis to make decisions and recommendations Coordinates and participates in assay validation Coordinates and participates in assay transfers Projects In house reagent replacement / validation Coordinate projects with supervision Coordination of projects within group Coordination of projects within department Coordination of projects between departments Writes reports and summaries Is called upon by other groups in QC for collaboration or
SME Is called upon by other departments for collaboration or SME Skills Information/data summarized in concise format Represent department at meetings Demonstrates creativity and contributes original suggestions Troubleshoot/Problem solving beyond method defined action Locate answers from other areas/consult with other areas Seeks development opportunities Technology Use of Word and Excel Use of QM software for data management (LIMS) and use of MRP
inventory software Use of deviation software (Trackwise) and monitoring software
(PDCS) Use of IDEA for Con (Document system) Use of IDEA for Sub (Document submission system) Requirements\: Bachelors’ degree in a relevant scientific discipline from an
accredited institution is required, plus eight to twelve (8-12)
years of relevant experience preferred; or Master’s degree in a relevant scientific discipline from an
accredited institution, plus four to eight (-48) years of relevant
experience preferred; or PhD in a relevant scientific discipline from an accredited
institution, relevant experience preferred Through understanding of scientific concepts and principles and
complex lab techniques. Able to manage portions of major projects with supervision or
minor projects independently. Develop/validate methods and processes. Performs and documents work following established methods, SOP’s
and/or GXP. Good understanding of applicable regulations and impact to
project and/or business. Able to interact with regulatory agencies. Comprehensive understanding of processes in immediate area and
familiarity of processes in other areas. Makes routine decisions with limited guidance from
supervisor. Recognizes and reacts to the significance of data/results. Able to effectively communicate procedures, thoughts and ideas
in a clear concise and appropriate manner within and outside of own
department. Communicates with cross-functional groups. Documents and reviews lab results/data as required by applicable
SOP’s and methods. Organizes data generated for inclusion in reports. Write and revise SOP’s, methods, and protocols. Able to train others on methods and routine lab work. Cooperates and shares information with other groups and
departments to accomplish goals. Contributes original suggestions and acts independently to find
answers and solutions. Thorough understanding of scientific concepts and principles and
complex lab techniques including aseptic technique. Trend different types of data (EM and process) in order to
provide timely reports. Physical Demands / Surroundings\: Lifting, carrying, pushing or pulling up to 50 pounds
occasionally Frequent periods of sitting, walking, and standing Occasionally must climb stairs or ladders, balance, bend or
stoop, crouch or squat Occasional low level work, fine finger dexterity/ including
grasping or pinching required Writing and use of a computer keyboard frequently Occasional use of personal protective equipment Visual / Hearing Demands\: Color vision and depth
perception required. May require extended hours at a computer
screen. Must be able to read electronic documents of all
types. Hearing acuity required. Eligibility
Requirements\: 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 older 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; 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 , Scientist III, Microbiology Quality Control, Other , Saint Joseph, Missouri
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