- Entry level
- No Education
- Salary to negotiate
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Microbiology Quality Technical Lead. This position can be based in one of the following locations: Fort Washington, PA or Lancaster, PA
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The Microbiology Quality Technical Lead will serve to help establish, maintain, and update microbiology quality assurance programs, procedures, and controls. Based on these activities, this role provides support to manufacturing plant QC microbiology labs to implement continuous mitigation and improvement programs, and provides support to internal and external business partners on microbiological control fundamentals to prevent and eliminate contamination during production.
In this role, you will ensure compliance with company policies, procedures, and quality standards, as well as safety and environmental regulations.
Responsibilities include, but are not limited to:
Helps to develop solutions to problems of moderate scope and complexity, and writes and assists others in writing standard operating procedures.
Provides technical assistance to QSE Microbiological activities; provides support to product review functions, generates moderately complex summaries; provides support to good manufacturing practice auditing. Technical input includes AET strategy, USP and method suitability studies, water and environmental validation samples, stability studies and setting microbiological specifications/acceptance criteria for cross-functional teams and other technical groups.
Partners with cross-functional groups to assess and ensure adequacy, control and robustness of manufacturing processes, water test methods, environmental monitoring, cleaning and sanitization; microbiological test methods and associated quality control processes at both internal and external manufacturing sites
Serves as an advisor to review selected quality issues (Investigation, CAPA’s trends, etc.) and recommend actions to assure adequate depth and scope of response. This may include participation in internal and external audits, technical compliance assessments or ad hoc attendance at management review meetings.
Demonstrates detailed knowledge of own technical area, and moderate knowledge of other areas impacted by own function at a local level with an operational focus, in contributing to regional projects and strategies.
Assists and provides instruction to laboratory colleagues in solving complex problems.
Participates in technical groups to implement laboratory activities, and solve complex problems, while complying with local and global regulatory requirements as well as J&J standards.
Supports the roll-out of laboratory activities
Contributes to external and/or internal manuscripts, regulatory reports, and technical reports.
A minimum of a Bachelor's degree in Microbiology, Biology or closely related field is required.
A minimum of 6 years of work experience in a Quality Assurance/QC Microbiology environment is required.
Relevant experience in a highly regulated industry in the field of QA Microbiology is required.
Familiarity with USP is required.
Knowledge and competency in application of FDA and other required regulations is required.
Experience writing, modifying and revising SOPs is required.
Fundamental knowledge of regulatory requirements, such as current GMP regulations is required.
The ability to review and understand microbiological test data is required.
Current experience with a variety of microbiological tests of raw materials and finished product is highly preferred.
Experience with training laboratory and non-laboratory personnel is highly preferred.
Experience with microbiological contamination control in manufacturing is preferred.
This position may require up to 10% domestic travel as business demands.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.