Quality Control Chemist II
Boston Analytical is a premier cGMP compliant laboratory, FDA and DEA registered for pharmaceutical analytical testing. We provide the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical, and Medical device companies worldwide. Since 1987, Boston Analytical has been and remains dedicated to customer satisfaction, and to the fast and accurate analysis of our clients’ products. The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.
Primary Duties and Responsibilities
- Prepares and analyzes products to determine chemical and physical properties.
- Documents work in a clear and organized manner.
- Will perform work under partial supervision and will provide over site to projects and assist other Chemists as needed.
- Works under partial supervision with chemists and other client personnel regarding research, procedures performed, related results and prepares reports.
- Is a subject matter expert in some techniques and will mentor others. Work to learn and improve on others techniques and tasks.
- Performs data generation, analysis and more complicated problem solving with a minimal rework.
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
- Works under partial supervision to ensure all work performed is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
- Follows all safety rules and regulations and conducts periodic safety audits.
- Follows all cGMP rules and regulations.
- Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.
- Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
Requirements & Qualifications:
Qualification include a Bachelor’s degree in Chemistry or a related discipline is required with 1-5 years of related experience. Knowledge of cGMPs and related compliance regulations and guidances required. A strong background utilizing IC technology and Chromeleon software is highly desirable.
Minimum Skills Requirements:
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.