Analyst III Microbiology and Endotoxin

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Analyst III Microbiology and Endotoxin 

PURPOSE:

Provides technical scientific skills and leadership for assigned QC microbiology functions including validation, testing, reviewing, dispositioning, analytical investigation, change management, CAPA, troubleshooting and identifying new technology to ensure departmental deliverable, goals and metrics are met.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role Quality Control Analyst III Microbiology and Endotoxin        

• Provides technical resource for the validation  and testing of microbiological assays including endotoxin supporting biopharmaceutical products.

• Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Revises SOP’s affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
• Maintains and generates requested microbiology-related reports, such as lists of qualified compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
• Troubleshoot assays and analytical instrumentation, improve existing    methods used in testing to optimize efficiency wherever possible. Establishes/maintains, minimizes workload, streamlining existing systems and ensuring adherence to all appropriate guidance both internally and externally. Contributes to continuous improvement opportunities by developing methods coordinating validation and drafting SOP’s where necessary.
• Investigates questionable test results, writes investigation/test plans, initiates and investigates deviation and OOS/Invalid/Unexpected reports when applicable. Collaborates effectively with QA representatives to manage the initiation, investigation, and closure of incident reports.
• Gathers information necessary to support changes to microbiology methods according to approved procedures. Initiates Change Control requests in Bayer’s document management system and follows through until the completion of workflows.
• Interacts with regulatory agencies, customers and internal auditors/inspectors. Represents QC microbiology and endotoxin at operational and cross-functional meetings, prepares and presents information, provides decision making support at meetings and disseminates information back to QC microbiology.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications

• Minimum Education Bachelor's Degree in a science or technical field.
• Demonstrable experience with cGMP and regulatory compliance (FDA, EMA and other international agencies).
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
• Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
• Strong computer skills (Word, Excel, Access, Powerpoint).
• Prior experience in a QC microbiology testing laboratory.
• Ability to work independently with minimum supervision

Preferred Qualifications:

• Minimum Experience 3 years of experience in pharmaceutical or related industry or an equivalent combination of education preferred.

Employees can expect to be paid a $71,900.00 - $107,000.00 Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. 

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least June 24, 2025

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