US_Associate Scientist, Bio QC

Boehringer Ingelheim GmbH; Northern (KY); Hybride; USD 60 000 - 85 000; Plein temps

Résumé du poste

Boehringer Ingelheim seeks an Associate Scientist, Bio QC to perform bio-analytical tests across raw materials, in-process, and stability samples in a cGMP setting. You will train others, revise SOPs, and ensure data accuracy and compliance.

Required are degrees in science with relevant Bio QC experience, strong communication, and proficiency with Word/Excel and SAP-based data management.

Qualifications

• High school degree or GED with 5+ years Bio QC testing in cGMP or similar environment.
• Associate degree with 2+ years Bio QC testing in cGMP or similar environment.
• Bachelor's degree in scientific field; testing experience preferred.

Responsabilités

• Perform routine bio-analytical testing on raw materials, in-process, release or stability samples.
• Maintain reagents, supplies, and calibrated equipment.
• Prepare reagents and materials; calculate results; communicate results to supervisors.

Connaissances

Bio QC testing

cGMP

Data handling

Communication

Word & Excel

SAP

Document mgmt

Formation

High school or GED

Associate's degree in science

Bachelor's degree in science

Outils

SAP

MRP inventory

Document Management System

Description du poste

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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Associate Scientist, Bio QC performs 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. This role initiates, executes and completes assays as per validated procedures and within Quality and Compliance guidelines and communicates testing results, compliance and/or scheduling issues to supervisors.

Duties & Responsibilities

• Performs routine testing using a portion of the existing laboratory assays.
• Maintains laboratory reagents, supplies and calibrated equipment.
• Prepares reagents and materials.
• Calculates test results.
• Communicates schedule, test status and concerns.
• Reviews and approves results and test sheets.
• Revises a Pre-existing Standard Methods and SOPs.
• Trains others on methods & procedures.

Requirements

• High school degree or GED with a minimum of five (5) years of relevant Bio QC testing or relevant experience in a cGMP or similar environment.

OR

• Associate's degree in relevant scientific discipline and a minimum of two (2) years of Bio QC testing or relevant experience in a cGMP or similar environment.

OR

• Bachelor's degree in relevant scientific discipline with or without additional Bio QC testing experience.
• Bachelor's degree in a scientific discipline with one-plus (1+) years of Bio QC testing experience in a cGMP or similar manufacturing environment is preferred.
• Knowledge of basic scientific principles and techniques.
• Ability to effectively communicate in a clear, concise and appropriate manner.
• Documents results and data clearly and accurately.
• Effectively interacts with co-workers and others as needed.
• Demonstrates teamwork within own group and other internal groups.
• Use of Word and Excel, QM software for data management (SAP), MRP inventory software, and Document Management System)

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.