Microbiology Quality Assurance Supervisor

2 weeks ago


Allendale, New Jersey, United States ESR Healthcare Full time
Position Title: Microbiology Quality Assurance Supervisor

Company: ESR Healthcare

About the Role:
This position is pivotal in overseeing and guiding the Quality Control Microbiology team to ensure compliance with current Good Manufacturing Practices (cGMP). The supervisor will be responsible for establishing key performance indicators (KPIs) and maintaining high standards of microbiological quality control.

Key Responsibilities:
1. Lead and manage daily operations, adjusting workflows and ensuring adherence to quality compliance.
2. Investigate and document any non-conformances and environmental deviations.
3. Recommend and implement process enhancements to boost efficiency and meet quality objectives.
4. Collaborate with other departments to align best practices and procedures.
5. Participate in both departmental and cross-functional meetings to promote quality culture.
6. Ensure compliance with regulatory standards by fostering a quality-oriented environment.
7. Engage with internal and external stakeholders to facilitate proper sampling and address inquiries.
8. Author and update Standard Operating Procedures (SOPs) and related documentation.
9. Review microbiological and environmental monitoring data, compiling reports on trends.
10. Support staff development through constructive feedback and performance evaluations.

Qualifications:
- Bachelor’s degree in Microbiology or a related field is required.
- A minimum of 8 years of experience in environmental monitoring within the biopharmaceutical sector.
- Strong understanding of microbiological testing methodologies and quality systems.
- Proficiency in MS Office applications, including Excel.
- Experience in supervisory roles, including hiring, training, and performance management.

Join ESR Healthcare:
Become a vital part of our commitment to quality and excellence in the biopharmaceutical industry. We value our employees and are dedicated to fostering a collaborative and innovative work environment.

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