Johnson & Johnson is currently seeking a QC Scientist (3rd shift) to join Janssen Ortho LLC organization located in Gurabo, PR.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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The QC Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, bulk, finished, combination products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs and participate on investigations when questionable analytical results have been generated. Operates and maintains laboratory instrumentation following the established methods and procedures. Prepares testing solutions and samples according to written instructions. Documents accurately all raw data in a legible manner at time of execution, following the Good Documentation Practices. Maintains complete and accurate records. Takes training of methods and procedures prior to execution. Performs any special task assigned by QC Management in support of Order Release Department. Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support the supply chain process.
Key Responsibilities:
- Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials, drug product and/or combination product testing and special projects. Assures to follow QC initiatives and requirements.
- Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required.
- Operates, with the proper training, laboratory instrumentation required for testing, such as: UV-Visible Spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, melting point apparatus, analytical balances, polarimeters, GC, HPLCchromatographs, X-Ray, SprayView, SprayTec, Empower and any other computerized system. Assures all equipment used for any testing is properly calibrated and PM is still within due date prior use.
- Actively participates in projects, safety and environmental, GMP's, SOP's trainings, and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/ GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area
- Maintains accurate, complete and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated.
- Works on special projects such as equipment calibration, process validation and cleaning and method transfers.
- Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety.
- Approves, if necessary, documentation of data generated by QC Scientist in a timely manner and according to specifications
Qualifications
Education:
- A minimum of a bachelor's degree in chemistry is required.
Experience and Skills:
Required:
- A minimum of 6 months of related work experience.
- Knowledge of cGMP's and compliance.
- Technical knowledge of Chemistry.
- Broader knowledge of basic sample preparation techniques.
- Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry etc.
- Computer and Software skills.
- Working knowledge of Empower, Tru Vault Document Management, and/or eLIMS systems.
- Technical writing skills.
- Problem solving/troubleshooting.
Other:
- Previous work experience in a Pharmaceutical Industry is preferred.
- PR Chemist License is preferred.
- Proficiency in both languages English and Spanish (oral and written) is required.
- This position requires availability to work the third shift from 9:30pm to 5:30am.
- This position may require a 10% of 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.