Quality Microbiology Lead
Company: Johnson & Johnson
Location: Fort Washington
Posted on: April 10, 2021
Johnson and Johnson Consumer Inc. is recruiting for a Quality
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
Are you interested in joining a diverse team delivering outstanding
results to our customers? Apply now for this exciting
- Develop an annual micro risk assessment, micro and analytical
lab audit schedule. Conduct the assessments and audits on time, per
- 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
- Perform audits of microbiology media suppliers
- Develops mitigation plans to remediate risk for microbial
- 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
- Train personnel on microbiological compliance.
- 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
- 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
- GMP experience in Pharmaceutical, Medical Device, OTC Drug,
Cosmetic and/or Food and Dietary Supplements Production is
- Master's Degree or higher is preferred.
- 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
- 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
- This position may require up to 25% domestic and/or
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
Keywords: Johnson & Johnson, Philadelphia , Quality Microbiology Lead, Other , Fort Washington, Pennsylvania
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