QC Chemistry Scientist (2nd shift)

Johnson & Johnson Innovative Medicine•Gurabo, PR

1d•Onsite

About The Position

We are searching for the best talent for a QC Chemistry Scientist (2nd shift) to be located at Gurabo, PR. The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, bulk and finished products, and utilities (i.e., water, etc.) in accordance with internal and compendia specifications. This involves conducting thorough testing to ensure that all products meet established quality standards. In addition to testing, the QC Chemistry Scientist participates in investigations whenever questionable analytical results are generated. This investigative aspect is crucial for identifying and addressing any deviations from expected results, ensuring the integrity of the testing process. Also operates and maintains laboratory instrumentation following established methods and procedures. Prepares testing solutions and samples and accurately documents all raw data in compliance with Good Documentation Practices. Maintaining complete and accurate records is essential for traceability and accountability in the laboratory environment. Additionally, the QC Chemistry Scientist undergoes training on methods and procedures and may perform any special tasks assigned by QC Management in support of the Order Release Department. This ongoing training ensures that the scientist is up to date with the latest techniques and regulatory requirements. Finally, must ensure compliance with all quality control policies, procedures, and systems to facilitate the timely release of high-quality products and support the supply chain process. It is important to note that failure to perform these functions effectively may result in product recall, production delays, and/or back-order status.

Requirements

Bachelor of Science (BS) in Chemistry is required.
Chemist license is required.
A minimum of two (2) years of relevant experience within pharmaceutical industry is 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, Volumetric, TOC, FTIR, pH meters, etc.
Computer and Software skills.
Working knowledge of Empower, Document Management, and eLIMS systems.
Technical writing skills.
Problem solving/troubleshooting.
Bilingual (English & Spanish).
This position is required to work the 2nd shift.

Nice To Haves

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

Responsibilities

Perform laboratory analysis and activities in accordance with cGMP practices, internal and external regulations, and supply chain cycle time goals.
Follow laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules.
Comply with laboratory schedules for raw materials and drug product testing and special projects.
Adhere to QC initiatives and requirements.
Verify documentation of data generated by other QC scientists in a timely manner and according to specifications.
Ensure correctness and inform supervisors and managers of any encountered deviations for proper investigation and corrective action plan.
Maintain all tested solutions and samples until lot release for any necessary laboratory investigation.
Operate laboratory instrumentation required for testing, such as UV-Visible Spectrophotometers, FTIR, pH meters, viscometers, analytical balances, GC and HPLC, chromatographs, Empower, and any other computerized systems.
Ensure all equipment used for testing is properly calibrated and preventative maintenance is up to date prior to use.
Actively participate in projects, safety and environmental, GMPs, SOPs training, and others as required.
Participate in special activities promoted by the company to foster employee involvement and professional development/growth, such as environmental/safety/GMP improvement projects to simplify, reduce, minimize, or eliminate environmental or compliance aspects in the job area.
Maintain accurate, complete, and neat records of all work performed.
Report results and deviations clearly, concisely, and accurately within the assigned standard time for each material.
Limit the generation of errors.
Work on special projects such as equipment calibration, process validation, cleaning, and method transfers.
Comply with laboratory schedules for raw materials and drug product testing on special projects.
Maintain the hazardous material storage area in full compliance and optimum housekeeping conditions.
Ensure all containers and glassware are properly labeled always during usage.
Assure proper disposal and report any encountered spill deviations related to environmental compliance or safety to
Actively participate in projects, safety and environmental, cGMPs, SOPs training, and others as required.
Participate in special activities promoted by the company to foster employee involvement and professional development/growth, such as environmental/safety/GMP improvement projects to simplify, reduce, minimize, or eliminate environmental or compliance aspects in the job area.
Approve, if necessary, documentation of data generated by QC Scientists in a timely manner and according to specifications.