Manager, Quality Control Microbiology

Job Title: Manager Quality Control

Location: Pearl River, NY

Scope: This position will have direct reports

RESPONSIBILITIES:

• Demonstrate expertise in performance of activities in the Microbiology group by strictly adhering to site procedures, Federal Regulations, and cGMP guidance

• Ensure the laboratory is maintained in an audit ready state at all times and represent the department during audits/inspections as a subject matter expert

• Facilitate team compliance via quality systems such as change control, CAPA and deviation investigations.  Support daily laboratory operations, including resolution of test schedule conflicts, review of data, assisting analysts in troubleshooting activities and incident investigations

• Assist with maintaining safety of the laboratory work area

• Provide microbiological testing and support to the Microbiology and Manufacturing departments

• Ensure individual training requirements are maintained as well as participate in cross-training activities.  Ensure the level of cross-training within the team is sufficient to meet the business needs.

• Effective interaction with other departments (internal and external). In particular, close contact maintained with the Microbiology, Production, Validation, Manufacturing and Planning Departments, & QA

• Actively contribute to continuous improvement initiatives in the lab

• Identifies areas of opportunity and leads continuous improvement projects. Directly supports manufacturing operations and serves as technical expertise in making decisions

• QC Micro representation at cross functional meetings

• Conduct duties in a safe manner and report all safety issues or concerns

BASIC QUALIFICATIONS:

• Bachelor Degree required in Microbiology/Biological Sciences with>8 years' of industry experience OR

• Master Degree in Microbiology/ Biological Sciences with >5 years' of industry experience AND

• Experience in a cGMP/Quality environment

• Experience of routine QC operations, including testing and documentation practice

• Audit/Inspection AND Method Validation experience

• Knowledge of microbiological techniques including sterility, bioburden, microbial identification and environmental monitoring.

• Must be able to work off shift

• Minimum 3 years' experience as a manager with direct reports (i.e. experience in performance reviews, scheduling tasks and project assignments)

OTHER SKILLS/COMPETENCIES:

• Exceptional attention to detail and strong writing skills are crucial

• A natural influencer, and ability to work effectively in cross -functional teams

• Proven leadership, verbal and written communication, organizational, critical thinking, and action oriented

• Proven logic and decision-making abilities

• Knowledge of continuous improvement techniques and problem-solving skills

PREFERRED QUALIFICATIONS:

• Experience with laboratory electronic systems

• Proficient using Microsoft Office

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.