in-process, finished product and stability testing using instrumental (such as HPLC/UPLC, TOC, DSC, TGA, FTIR, UV-Vis and Dissolution apparatus) and wet chemistry for raw materials (LOD, ROI, KF, Viscosity, p H and others) Performs routine analyses of cleaning swab samples using NPOC/TOC and HPLC techniques.
Performs routing analyses of raw materials using USP/NF or in-house testing methods. Executes analysis required per protocols and compiles data into reports. Performs instrument qualifications/calibrations of laboratory equipment, as applicable. Performs all assigned tasks in a timely and organized manner in accordance with c GMP, OSHA, GLP and company policies and procedures. Assists
other group members, specifically senior level, with new and existing projects. Assists in analytical methods verifications, validations, or transfers. Assists during investigations and troubleshooting of analytical problems.
Maintains good c GMP practices by following detailed SOP's, laboratory notebook, training records, and good documentation practices. Operates and maintains various analytical instrumentation and equipment per established work instructions and SOPs. Maintains safe and clean working environment by performing routine laboratory housekeeping and reporting unsafe conditions. Assists in creating and revising of standard operating procedures, work instructions and analytical
test methods. Performs other duties as directed by management and senior analytical chemists.
Implements and maintains quality systems, policies and procedures that ensure compliance to ISO 9001/13485, GLP, c GMP, FDA (i. e. 21 CFR11, 820, 210, 211) and other applicable standards. QUALIFICATIONS Background and understanding for working in a Regulated (ISO, FDA and EU c GMP) environment Experience in utilizing HPLC and common laboratory instruments Knowledge of medical and finished product manufacturing, analytical testing. Other techniques include DSC, TGA, FTIR, dissolution, p H, viscosity, moisture, titrations, etc. desirable. Knowledge of plastics manufacturing and associated analytical testing is highly desirable.
Demonstrates interpersonal, communication, and motivation skills Attention to detail is crucial in this position. Able to work closely with other internal departments. Flexible in handling multiple and changing work assignments. Self-reliant in determining priorities and setting schedule to meet goals and objectives. Ability to effectively present information and respond to questions. EDUCATION AND/OR EXPERIENCE Bachelor’s degree in chemistry or equivalent with minimum of 2-4 years of laboratory experience in the medical industry or GMP environment Quality Control/Quality Assurance Knowledge of GMP compliance Knowledge of Compendia USP, General Chapters, Notices, and Procedures Good MS Office skills Good interpersonal, verbal and communication skills Efficient working independently, as well as a team member Comfortable in a fast-paced, small company environment, ability to adjust workload based upon changing priorities.
LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write detailed procedures and work instructions.
Ability to communicate effectively MATHEMATICAL SKILLS Ability to work with mathematical concepts and fundamentals of applied statistics. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY Exercises judgment within generally defined practices and policies for selecting methods and techniques for obtaining solutions. Makes sound decisions and applies appropriate notification to management as appropriate. Ability to deal with problems involving several variables in standardized situations. PHYSICAL DEMANDS While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; and talk or hear.
The employee must occasionally lift and/or move up to 50 pounds. PIad2bcff787eb-26276-33140238For more details: jobs-search. org/analytical-chemist_putnam-c427006/analytical-chemist-putnam_i1976188901
