Quality Control Microbiology Lab Supervisor
About the Role
The Microbiology Lab Supervisor is responsible for the safety, organization, administration and supervision of the Lab Analysts. Leading, mentoring, and developing a high-performing team to ensure the timely and accurate testing of raw materials, in-process samples, and finished goods in accordance with internal and compendia specifications. This role balances technical microbiological expertise with strong people leadership to ensure laboratory compliance (GMP/GLP) while promoting a culture of safety, continuous improvement, and employee engagement. Assures compliance with all quality control policies, procedures and systems to ensure the timely release of high-quality products in support of the supply chain process.
Responsibilities
- Mentors and supervises quality control employees, evaluates performance, and conveys goals effectively to enhance product quality and customer satisfaction.
- Provides technical and regulatory guidance related to lab operations and seeks continuous process improvements in cost, quality, and compliance.
- Review/approve test data, technical reports and standard operating procedures.
- Assures all laboratory responsibilities are performed in accordance with internal and external regulations and policies and consistent with supply chain cycle time goals.
- Adhering to all state and federal regulations, including FDA, EPA, OSHA, and DEA guidelines, as well as following company and site-specific policies and procedures.
- Participates in global initiatives, performs gap assessments, and provides input for quality control reports, budget planning, and project leadership on method transfers, validations, and equipment purchases.
- Upholds the Johnson & Johnson Credo, promoting safety and personal development while ensuring regulatory compliance of laboratory operations.
- Serves as an SME or in a support role for inspections and audits.
- Contributing insights to address intricate investigations, focusing on identifying the root cause and implementing effective corrective and preventive measures, all while ensuring the prompt resolution of laboratory inquiries.
Qualifications
Required:
- A minimum of 2 years of experience in a QC Microbiology lab within the pharmaceutical industry or relevant military experience.
- A minimum of 2 years of experience in a supervisory or team lead role, with demonstrated ability to develop staff.
- Excellent communication and conflict handling skills.
Preferred:
- Strong working knowledge of FDA regulations, USP standards, GMP/GLP requirements and Contamination Control Strategy Programs.
- Experience in aseptic techniques.
- Ability to inspire and motivate associates, fostering a collaborative project team environment.
- Highly detail-oriented with excellent communication, organizational, investigative, and negotiation/influencing skills.
- Must possess the capability to make crucial decisions for effectively managing laboratory teams while recognizing and discussing interdependencies and impacts with upper management.
- Decisions and problem-solving in this role must align with higher-level organizational and business needs, ensuring full consideration of regulatory requirements, sound business practices, and scientific validity.
- Must demonstrate strong organizational agility, enabling rapid and effective responses to dynamic business needs.
Schedule
This position may require availability for working multiple shifts, including irregular (non-standard) shifts and/or weekends.