LGM Pharma is a leading contract development and manufacturing organization (CDMO) and provider of Active Pharmaceutical Ingredients (API). With excellent API sourcing and supply chain expertise together with our drug product contract development and manufacturing solutions, LGM is a premier end-to-end solutions provider to the global pharmaceutical industry.

We are a high-growth organization looking to accelerate the development and commercialization of high-quality therapeutics worldwide. We have offices in California, Texas, Kentucky, Florida and Israel.

RESPONSIBILITIES:   

• Issues labeling to packaging department and records issuance on packaging record.
• Maintains labeling reconciliations and documentation as required by SOP’s and good manufacturing practices (GMPs).
• Coordinates the approval or rejection of all labeling as well as the destruction of current labeling inventory which may have become obsolete.
• Performs labeling activities (inspection, count, maintain locations and inventories in the inventory system, etc.) as required by SOPs.
• Performs serialization labeling tasks as required.
• Performs in-process inspections and physical testing of products to ensure compliance with specifications, including but not limited to bulk and tapped density, weight variation, friability, disintegration, and LOD.
• Performs inspection and sampling of incoming raw materials and retest materials for delivery to the Quality Control Laboratory according to established SOPs.
• Completes raw material receipt records, ensure proper labeling of raw material containers, execute release or other disposition of raw materials, and operation and maintenance of the sampling chamber in accordance with standard operating procedures.
• Maintains all analytical equipment and instrumentation utilized for QA physical testing in accordance with written procedures.
• Coordinates collection of finished goods samples for reserve/retain samples.
• Performs review of In-process QA testing data in a timely manner.
• Performs batch record review for accuracy and completeness.
• Complies with cGMP regulations and follow all standard operating procedures.
• Other related duties as required.

QUALIFICATIONS:  

• High school diploma or general education degree (GED). 
• 1+ year experience in a Quality Assurance environment and/or chemistry laboratory is preferable.
• Solid organization, attention to detail, and communication skills, both written and verbal.
• Able to apply basic math concepts
• Able to work with others in a positive team environment. 
• Ability to routinely lift and move up to 50 pounds.
• Able to stand for long periods of time.