Quality Control Microbiology Lab Supervisor

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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 and 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.
• Adheres 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.
• Contributes 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

• Education: A minimum of an associate degree and/or bachelor’s degree in microbiology or a related science field is preferred.
• 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.

Skills

• Collaboration
• Compliance Management
• Controls Compliance
• Corrective and Preventive Action (CAPA)
• Developing Others
• Inclusive Leadership
• ISO 9001
• Leadership
• Operational Excellence
• Persistence and Tenacity
• Quality Auditing
• Quality Control (QC)
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Report Writing
• Technologically Savvy