Compounding Inspector

Sheffield Pharmaceuticals•New London, CT

5d•Onsite

About The Position

Under general supervision, this role provides support to the compounding department. Responsibilities include the examination of retain samples, assisting incoming inspectors with raw material sampling and AQL inspection, and the release (buyoff) of incoming product components. The position also assists in non-analytical laboratory maintenance or administrative functions as needed. Essential job functions include complying with cGMP, SOP's, GLP's, Company Policies & Practices, and Safety requirements. The inspector performs compounding inspections of mixers, holding tanks, and other equipment according to established procedures, and conducts in-process sample testing. Maintaining complete, accurate, and legible records of all analyses in a laboratory notebook is crucial. The role involves quality control inspection of retain samples to ensure fill weights match specifications, carton artwork matches specifications, and lot codes & expiration dates are correctly printed on tubes, cartons, and master cases. A key aspect is maintaining proper liaison with all departments to foster a team philosophy. The inspector is responsible for following all safety regulations and complying with SOP's, DEP, EPA, OSHA, FDA, and cGMP's. This includes following all Environmental and OSHA requirements and attending in-house training sessions. The laboratory must be maintained in a neat and organized manner, and assigned procedural training must be completed in a timely manner. Any issues encountered during the performance of duties must be reported to laboratory management. Related duties may be assigned.

Requirements

Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), GLP and other regulatory requirements.
Knowledge of Code of Federal Regulations, 21CFR, part 210 and 211.
Knowledge of English usage, spelling, grammar and punctuation.
Knowledge of Basic Principles and practices of solution preparation and analytical instrumentation.
Knowledge of Basic Principles of mathematical calculations.
Knowledge of Basic Principles of computer systems.
Ability to communicate clearly and concisely, both orally and in writing.
Ability to establish and maintain cooperative working relationships with those contacted in the course of performing assignments.
High School Diploma or equivalent.
Ability to work 3rd shift hours - 11:00 PM to 7:30 AM

Nice To Haves

Associate degree preferred in related field.

Responsibilities

Perform Compounding inspection of mixers, holding tanks and other equipment according to established procedure.
Perform in-process sample testing.
Maintain complete, accurate and legible record of all analyses in a laboratory notebook.
Performs quality control inspection of retain samples to ensure that fill weights are as indicated on the tube and carton artwork on tubes and cartons match specification, lot codes & expiration are correctly printed on tubes, cartons & master cases.
Maintain proper liaison with all departments to contribute to the team philosophy
Responsible for following all safety regulations and complying with SOP's, DEP, EPA, OSHA, FDA, and cGMP's while performing duties
Follow all Environmental and OSHA requirements.
Attend in-house training sessions.
Maintain the laboratory in a neat, organized manner.
Perform assigned procedural training in a timely manner.
Informs laboratory management or issues encountered during the performance of duties.
Perform related duties as assigned.