Quality Microbiology Lead

Company: Johnson & Johnson
Location: Fort Washington
Posted on: April 10, 2021

Job Description:

Job Description

Johnson and Johnson Consumer Inc. is recruiting for a Quality Microbiology Lead!

Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S-- Baby, BAND-AID--, NEUTROGENA--, TYLENOL--, MOTRIN--, and LISTERINE--. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

The Quality Microbiology Lead provides leadership in the management of contract laboratories and microbiology risk assessments and investigations at internal and external manufacturers. Performs Microbiological risk assessments in non-sterile manufacturing facilities. Develops and monitors mitigation plans to remediate risk for microbial contamination. Leads microbiological investigations at the manufacturing facility and microbiology laboratory. Trains internal and external business partners on the fundamentals of microbiology and microbiological controls to prevent contamination during production. Partners with internal J&J resources to benchmark the bes industry practices on microbiological contamination prevention. Conducts Microbiology and Analytical laboratory audits for cGMP compliance and qualifies microbiological media suppliers.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

KEY RESPONSIBILITIES:

• Develop an annual micro risk assessment, micro and analytical lab audit schedule. Conduct the assessments and audits on time, per the schedule.
• Write the audit reports, gain senior management alignment for audit rating and publish audit reports in timely manner.
• Revise relevant SOP's which govern the assessment program.
• Coordinate and drive microbiology investigations at internal/external manufacturers and laboratories. Seek management alignment on micro risk ratings and outcomes from investigations
• Perform audits of microbiology media suppliers
• Develops mitigation plans to remediate risk for microbial contamination
• Play key role in influencing and participating in the microbiology community within J&J, through such channels as the Center of Excellence, Sterility Assurance and JJRC.
• Provide technical expertise regarding the interpretation and/or implementation of cGMP hygienic practices. Provide technical support to the new product introduction process, including review of raw material and finished product microbiological risk classifications, equipment train readiness, cleaning and sanitization practices, and remedial action plan development.
• Review and approve validation approaches/protocols and reports ensuring compliance to regulatory and company requirements as needed.
• Train personnel on microbiological compliance.
  
  Qualifications
  
  EDUCATION
  
  • A minimum of a Bachelor's degree or higher is required.
    
    Experience & Skills
    
    • A minimum of six 6 or more years of relevant work experience is required
    • Detailed working knowledge of cGMP requirements and current FDA/ Health Canada enforcement issues is required.
    • Proficiency in Microsoft Office tools (PowerPoint, Word, Excel and Outlook) is required.
    • Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability required.
    • Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority required.
    • Knowledge of SAP, TRu and EtQ is preferred.
    • Bachelor's of Science or higher degree in Microbiology or Biological Science with an emphasis in Microbiology is preferred.
    • GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production is preferred.
    • Master's Degree or higher is preferred.
      
      Other
      
      • Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with senior levels of management to inform, drive change, and provide direct feedback.
      • Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction. Proven ability to lead and influence others within product teams with excellent communication and presentation skills.
      • Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
      • This position may require up to 25% domestic and/or international travel.
        
        Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
        
        

Keywords: Johnson & Johnson, Philadelphia , Quality Microbiology Lead, Other , Fort Washington, Pennsylvania