Compounding Inspector - QC Lab - 3rd shift

Job Description

Job Description

Job Overview: Under general supervision provides compounding department support, examination of retain samples and assists incoming inspectors in raw material sampling & AQL inspection and release (buyoff) of incoming product components. Also, assists in non-analytical laboratory maintenance or administrative functions as needed.

Essential job functions:

• Comply with cGMP, SOP's, GLP's, Company Policies & Practices and Safety requirements.
• 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.

Required Knowledge and Skills:

Knowledge of:

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), GLP and other regulatory requirements.
• Code of Federal Regulations, 21CFR, part 210 and 211.
• English usage, spelling, grammar and punctuation.
• Basic Principles and practices of solution preparation and analytical instrumentation.
• Basic Principles of mathematical calculations.
• Basic Principles of computer systems.

Skilled in:

• Communicating clearly and concisely, both orally and in writing.

• Establishing and maintaining cooperative working relationships with those contacted in the course of performing assignments.

Physical Requirements and Working Conditions :

• Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 25 pounds, vision to monitor and moderate to loud noise levels. Incumbents may be exposed to, or work with, toxic or potent materials, toxic or noxious gases, electrical hazards, dangerous tools and equipment. Incumbents must be able to use personal protective equipment, (e.g. respirators, gloves, etc.).

Work is performed in a production or laboratory environment.

Minimum Qualifications:

• High School Diploma or equivalent. Associate degree preferred in related field.
• Ability to work 3rd shift hours - 11:00 PM to 7:30 AM