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Job Function:

Quality

Job Sub** **Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

Janssen Ortho LLC is recruiting for a Quality Control Scientist! This position will be located in Gurabo, Puerto Rico.

Position Summary:

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, HPLC chromatographs, 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. Complies with all Laboratory Schedules for raw materials and/or drug / combination product testing on special projects.

• 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.

• Actively participates in projects, safety and environmental, cGMPs, SOPs 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.

• 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 Degree is required with a focus in Chemistry preferred.

Required:

+ 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 eLIMS systems.

+ Technical writing skills.

+ Problem solving/troubleshooting.

Other:

+ Bilingual (English & Spanish).

+ At least 2 years of experience in Pharmaceutical Industry.

+ PR Chemist License is recommended.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy