In Bayer’s Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Analyst III QC Software Validation, are to: 

• Write validation protocols and final reports for computerized analytical instruments and non-computerized analytical instruments, and performs periodic reviews.
• Perform system administration tasks for QC systems. 
• Ensure validations are within compliance by accurately following relevant SOPs and performs all activities in accordance with cGMPs.
• Demonstrate ability to plan and prioritize moderately complex projects to meet goals
• Supports laboratory staff and cross functional areas
• Demonstrate a commitment to safety by following and promoting programs regarding health, safety and protection of environment.
• Coordinate vendors in support of validation projects.
• Support inspection-related needs as required.
• Work on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values.                                                                                                                                                                                                                 More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:                             

• Bachelor’s Degree in science or engineering or related discipline.
• Experience working in a cGMP compliant environment is essential.
• Must be knowledgeable with instrument qualification.
• Understanding of cGMP, 21 CFR Part 11, and regulatory compliance (FDA, EMA, and other international agencies).
• Support and prioritize many diverse activities simultaneously while meeting product release commitments.
• Ability to multi-task and able to adapt to changing business requirements in a dynamic corporate environment.
• Strong organizational skills. 
• Ability to work independently with minimum supervision.

Preferred Qualifications:

• Minimum of 5 years of experience of experience performing relevant activities.
• Familiarity with manufacturing process.
• Technical writing skills for reports and SOPs.

Employees can expect to be paid a salary of approximately $75,100 to $112,577.  Additional compensation may include a bonus or commission (if relevant).  Other benefits include health care, vision, dental, retirement, PTO, sick leave, etc. If selected for this role, the offer may vary based on market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.