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Scientist III, Microbiology Quality Control

Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: October 15, 2021

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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