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Speciality Quality Control Virology
PURPOSE:
Provides advanced technical scientific and leadership for assigned QC microbiology functions including sampling, testing, reviewing,
disposition, analytical investigation, change management, CAPA, troubleshooting and new technology identification/implementation that ensures departmental deliverable, goals and metrics are met. Acts as Subject Matter Expert (SME) for microbiology related issues.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role QC Specialty Virology:
Maintains subject matter expertise for USP/NF, EP, and JP compendia. 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 commercialproducts. Maintains records of method qualification/validation and other microbioligical related methods.Troubleshoot assays and analytical instrumentation, improves 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 IR’s and OOS/Invalid/Unexpected
reports when applicable. Collaborates effectively with QA representatives to manage the initiation, investigation, and closure of incident reports.Maintains close interaction and communication with the
Production, Supply Chain other QC divisions and QA groups to ensure ontime and dependable related decisions.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 at operational and cross-functional meetings, prepares and presents information, provides decision making support at meetings and disseminates information back to QC microbiology.Other related duties as assigned.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications
• 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), ACS and FCC requirements. Knowledge of biologics and manufacturing processes.
• Strong computer skills (Word, Excel, Access, Powerpoint).
• Prior experience in a QC microbiology testing laboratory (Bioburden, Microbial Identification).
• Knowledge of various microorganisms relative to habitat and pathogenicity.
• Knowledge of Virology/Cell Culture may be required.
• Experience with Supply Chain logistics and Quality Release process is desirable.
• Ability to work independently with minimum supervision
Preferred Qualifications:
• Experience 6 years of experience in pharmaceutical or related industry or an equivalent combination of education and experience. 2+ years experience in the relevant (business need) technical specialty within the field of protein characterization preferred.
The salary range for this position will be $ 94600.00 - 141900.00
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 July 3, 2025
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YOUR APPLICATIONBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.