Inteldot has over 14 years of experience in the life science industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job Summary:
The Chemist will perform analytical testing and support laboratory activities to ensure the quality, safety, and compliance of raw materials, components, and finished medical device products in accordance with client’s quality standards, regulatory requirements, and Good Manufacturing Practices (GMP). The ideal candidate is a detail-oriented professional with strong analytical skills, hands-on experience in chromatography, and the ability to work effectively in a fast-paced, regulated environment.
Responsibilities:
- Perform qualitative and quantitative chemical analyses using HPLC, UV-Vis, IR, and other analytical instruments.
- Execute testing following compendial methods (e.g., USP, EP) and internal standard operating procedures.
- Operate and maintain analytical equipment, ensuring calibration and preventive maintenance are performed as required.
- Utilize Empower Chromatography Data System for data acquisition, processing, and reporting of chromatographic results.
- Conduct routine and non-routine laboratory testing of raw materials, intermediates, and finished products.
- Document all testing activities in compliance with Good Documentation Practices (GDP) and GMP standards.
- Participate in laboratory investigations, out-of-specification (OOS) results, and non-conformance evaluations.
- Support method transfers, verifications, and validations as assigned.
- Collaborate with cross-functional teams to support production schedules and quality improvement initiatives.
- Maintain a safe and compliant laboratory environment, following EHS and company safety policies.
Education:
- Bachelor’s degree in chemistry (required)
- 3–5 years of relevant experience in a regulated laboratory environment (pharmaceutical, biotechnology, or medical device industry preferred).
- Licensure: Chemist License – Highly preferred
Technical & Soft Skills:
- Proficiency with analytical techniques: HPLC, UV-Vis, IR
- Working knowledge of chromatography principles and Empower software
- Familiarity with compendial methods (USP, EP) and analytical chemistry best practices
- Strong understanding of GMP, GLP, and ISO quality system requirements
- Excellent analytical, problem-solving, and organizational abilities
- Strong attention to detail and accuracy
- Effective communication and teamwork skills
- Ability to work independently and manage multiple priorities