USA
48 days ago
PR Chemistry
Full Time Contract Title: Chemist (PR License) Location: Dorado, Puerto Rico Length of Contract: 3 months with potential to extend up to 6 months Company Description: Our client is one of the largest medical device manufacturing facilities in the world, producing a wide range of products used in various medical specialties. Position Description: We are looking for a highly qualified Chemist with a valid Puerto Rico Chemist License to join our client's team. The ideal candidate will have a strong understanding of chemical principles, laboratory techniques, and regulatory compliance. This role will involve a variety of tasks, including conducting experiments, analyzing data, and ensuring adherence to safety protocols. Responsibilities: + Experience with Empower 3 Software + Ensure data integrity and compliance with regulatory standards (e.g., 21 CFR Part 11) within Empower 3. + Perform system administration tasks, including user management, security settings, and system configuration. + Review and approve electronic laboratory notebooks (ELNs) and other data generated in Empower 3. + Generate reports and export data for analysis and regulatory submissions. + Experience with LIMS (Laboratory Information Management System) + Manage sample workflows, including sample tracking, storage, and disposal. + Ensure accurate and timely data entry into the LIMS. + Generate reports on laboratory activities, including test results and trends. + Assist in maintaining the LIMS, including updates and troubleshooting. + Laboratory Investigations + Investigate deviations from standard operating procedures (SOPs) and identify root causes. + Implement corrective and preventive actions to prevent recurrence of deviations. + Document investigations thoroughly and accurately. + Method Transfers/Validation + Transfer analytical methods from development to routine testing, ensuring consistency and accuracy. + Validate analytical methods according to regulatory requirements (e.g., USP, EP). + Verify the performance of analytical methods to ensure they meet specifications. + Prepare and review validation protocols and reports. + USP/EP Compliance + Ensure adherence to USP and EP standards for analytical methods and testing procedures. + Select appropriate USP/EP methods for testing. + Prepare reference standards according to USP/EP specifications. + Implement USP/EP methods in the laboratory. Qualifications: + Valid Puerto Rico Chemist License + Strong understanding of chemical principles and laboratory techniques + Experience with analytical instrumentation, such as HPLC, GC, and spectrophotometry + Expereince with Empower 3 software and LIMS + Expereince w/ Laboratory investigations: CAPA and Deviations + Ability to interpret data + Excellent written and verbal communication skills Education & Certifications: + Bachelor's degree in chemistry or a related field with 5-8 years of experience. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job, duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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