Analytical Chemist III - 2nd Shift

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

 

POSITION PURPOSE

Responsible for assuring the accurate analysis of incoming raw materials, bulk liquids, and finished products utilizing Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak’s Test Methods (NPTM) Good Laboratory Practices (GLPs), and Good Manufacturing Practices (GMPs). Assures tested raw materials, bulk liquids, and finished products have met the required specification criteria prior to release.  Investigate out of specification results to determine final disposition.  Maintain accurate, complete and traceable documentation related to analysis and disposition.  Ensure the effective and efficient functioning of the Analytical Laboratory.  Designate appropriate and trained personnel to perform required tasks.  Review documentation to ensure adherence to internal and external requirements

 

 

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Testing Requirements:

• Performance of diversified chemical testing as needed by using current USP,  Standard Operating Procedures (SOPs), Work Instructions (WIs), (NPTM on raw materials, bulk liquids, and finished products.  The testing may include but is not limited to: pH determination, viscosity, refractive index, specific gravity, etc.  Conduct wet chemical titration to determine the percentage of activity on various solutions and raw materials, bulk liquids, and finished products.
• By the use of instruments (GC, HPLC, IR, UV, Auto-titrator, etc.) determine the percentage of various components as required by specifications.
• Perform identification of various chemicals or formulations as per methodology USP/NF and other test requirements
• Coordinate release of liquid batches including designation of reassay/expiration date.
• Assist in the sampling, testing and release of raw materials when needed
• Determine the toxicity and pH of waste tanks at designated intervals

 REPORTING & ANALYSIS:

• Ensure that all results are accurately recorded in appropriate laboratory logs or other designated forms
• Review all data generated by the laboratory associated with the manufacturing of Drug and OTC products
• Perform investigations into laboratory Out of Specification Results (OOS).

Lab Maintenance:

• Ensure that all instruments that perform analysis are validated and calibrated.
• Ensure that all Analytical Methods utilized for analysis of Drug and OTC products, at the least, are validated according to International Standards
• Purchase analytical supplies
• Prepare solutions and titrants when required
• Clean laboratory at specified intervals
• Perform calibration, reading, and recording of instruments within the Analytical Chemistry Lab
• Prepare and maintain laboratory test solutions

 Additional Requirements:

• Determine products’ disposition
• Complete necessary forms
• Lead, Direct and Train lower level Chemists ( I, II) in the use of instruments, methodology, SOPs, WIs, GLP, GMPs, etc.
• Furnish report to QC Lab Manager on a continuous basis.
• Assign workflow in the laboratory in conjunction with Analytical Chemist Senior Level.

 SPECIAL PROJECTS:

• Handles special projects and assignments as delegated (method transfer, method validation).

PERFORMANCE MEASUREMENTS

• Test raw materials, batches, and finished products in a timely manner.
• Ensure release of raw materials, batches, and finished products are done efficiently.
• Maintain Lab cleanliness in a timely manner.
• Ensure proper new / refresher training of Analytical I Chemists.