Manager, Quality Control Microbiology

Job Title: Manager, Quality Control Microbiology

Location: Pearl River, NY

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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. Serve as a coach and mentor to team members.

• 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 in sampling and testing as well as 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

About You

Education/ Experience:

• Bachelor’s degree in Microbiology, Biological Sciences, Biochemistry, Biotechnology, Chemistry, or a related scientific field with 8+ years of relevant work experience in a cGMP or Quality environment, or extensive industry experience

• Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams

• Knowledge of microbiological techniques including sterility, bioburden, microbial identification, environmental monitoring, culturing of both bacterial and viral isolates or tissue culture preferred. Previous Quality Control experience desired. 

• Exceptional attention to detail and strong writing skills are crucial.

•  Candidate should be familiar with cGMP guidelines must be able to work off shift and in a team environment.

Preferred Qualifications:

• Degree in Microbiology

• An understanding of routine QC operations, including testing and documentation practices.

• Professional writing capability.

• Experience with laboratory electronic systems

• Audit/Inspection Experience

• Method validation experience

• Proficient using Microsoft Office

• Proven logic and decision-making abilities and critical thinking skills.

• Knowledge of continuous improvement techniques and problem-solving skills

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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to gain experience and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take diligent care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at