Jj
Quality Assurance Manager Parenterals
Gurabo, Puerto Rico, United States of America
Sponsorship not specifiedDetected 2 days ago
GMPFDA RegulatoryResearchLeadershipCommunicationCollaborationMentoringMicrosoft Office
About the role
- As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
- We provide an inclusive work environment where each person is considered as an individual.
- Johnson & Johnson is an Equal Opportunity Employer.
Responsibilities
- Supports budget management, organizational structure and business requirements to accommodate business needs and assure metrics.
- Effectively supports launches of products and technologies.
- Partners with the Compliance Team to perform internal audits and support sites during FDA/International PAIs.
- Partners with other JSC functions (Sterility Assurance) to ensure consistent application of parenteral manufacturing practices.
- Performs corrective/disciplinary actions, when necessary, when company policies and procedures are not followed.
Requirements
- A minimum of 6 years of related work experience in pharmaceutical industry and parenteral products is required.
- A minimum of a bachelor's degree in science or related field is required.
- Knowledge of cGMP's, record control specifications, and experience in regulatory inspections.
- Requires overall experience in the Quality Assurance Unit.
- Knowledge in equipment and process validation, environmental, Microbiological challenge environment, release, regulatory, lyophilization and troubleshooting of aseptic products.
- Knowledge of lyophilization and sterilization processes.
- Proven experience in implementing quality systems.
- Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies.
- Experience in the management of regulatory inspections.
- Strong communication skills, ability to write and speak in English and Spanish is required.
- Knowledge of cGMP's, record control specifications, and experience in regulatory inspections. Requires overall experience in the Quality Assurance Unit.
- Develops and implements strategy for GMP's compliance for the site.
- Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies. Experience in the management of regulatory inspections.
- This position may require up to a10% of domestic and/or international travel
Nice to have
- Knowledge of contamination controls and combinations products is preferred.
- Leadership skills is preferred.
- Proficiency with MS Office tools is preferred.
- Preferred Skills:
Benefits
- 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.
- Assures that all assigned personnel have the education, training and experience, or a combination of these, in order to carry out all job duties and responsibilities.
Company info
- At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
This listing is sourced directly from Jj's careers page and normalized into a canonical job model.