Analyst, Quality Control
About The Position
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. Learn more at https://www.jnj.com/. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Analyst, Quality Control. The chosen candidate will be responsible for conducting complex test and analysis to assure that product comply with established specifications.
Requirements
- A Bachelor’s Degree or Equivalent is required with major on Science preferred.
- Good interpersonal relations and communication skills required
- Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended
- Demonstrated knowledge and expertise in quality processes and regulatory requirements.
- Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 and/or 21 CFR Part 4)
- Basic Spectroscopy knowledge (theorical and practical) to evaluate and troubleshoot chromatography analysis, document and review chromatography and/or spectroscopy (GC, UPLC, HPLC, FTIR, etc.) results that could impact the results for the test performed.
- Basic wet chemistry techniques related to qualitative and quantitative
Responsibilities
- Performs raw material, in-process and/or finished goods tests and reviews.
- Able to work in an environment with chemicals safely.
- Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.
- Monitors and reviews environmental charts and/or numeric data.
- Performs chemical and sterility release of product.
- Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.
- Carries out difficult calculations and prepares documentation that shows the results for the test performed.
- Prepares media and performs quality assurance control checks per USP.
- Investigate and write out of specification reports.
- Read and interpret results, performs trend analysis as required.
- Recommends, amends and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
- Performs other duties assigned as by any member of Laboratory Management.
- Execute simple microbiology analyses in-process sample and finish products (Microbial count, Environmental Monitoring and sterility test) to comply with current procedures and Pharmacopoeias.
- Basic knowledge on microbiology principles, theories, practices and methodology.
- Basic Technical writing techniques knowledge to perform preliminary laboratory investigation.
- Completes record of inspection results, acceptance, rejection and disposition for entry into logbooks or computer systems (i.e. LIMS).
- Support process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)
- Responsible to ensure adequate systematic control of nonconforming product.
- Recommends and implements revisions, corrections and changes to test equipment, procedures and methods.
- Experience on proper use and basic troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS.
- Participates on special requests for product testing, such as qualification protocols
- Initiates and coordinates discussions with quality, engineering and other relevant departments to develop corrective actions for reoccurring problems
- Conducts training for lower level technicians and operations.
- Cross-trains to support other functional areas.
- Ensures proper safety and environmental procedures and practices are utilized
- Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
