Job Description:

Description

Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 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 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. Maintain accurate, complete, and traceable documentation related to analysis and disposition.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Testing Requirements:

• Understanding of USP, Standard Operating Procedures (SOPs), Work Instructions (WIs), Test Methods related to raw materials, bulk liquids, and finished products.


• The testing may include but not limited to: pH determination, viscosity, refractive index, specific gravity


• Conduct wet chemical titration to determine the percentage of activity on various solutions and raw materials, bulk liquids, and finished products and by the use of instruments such as: GC, HPLC, IR, UV, Auto-titrators


• 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


• Assist in the sampling, testing and release of raw materials when needed.


• Perform calibration, reading, and recording of instrument data within the Analytical Chemistry Lab


• Prepare and maintain laboratory test solutions, titrants inventory


• 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.

Additional Requirements:

• Provide support for purchasing analytical supplies


• Clean laboratory work related area


• Determine products' disposition


• Complete necessary forms


• Coordinate release of liquid batches including designation of reassay/expiration date.

PERFORMANCE MEASUREMENTS

• Test raw materials, batches, and finished products.


• Ensure release of raw materials, batches, and finished products are done accurately and timely.


• Maintain Lab cleanliness.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelor's degree in Chemistry, Analytical Chemistry, other related science

REQUIRED KNOWLEDGE:

• Understand Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA)


• Classical Analytical lab techniques (titration, pH, Specific gravity/Density)

EXPERIENCE REQUIRED:

• A minimum of three (3) years' experience in a laboratory environment (Analytical Chemistry Lab preferred)

SKILLS/ABILITIES:

• Proficiency in reading, writing and speaking English


• Ability to read and comprehend Company policies and procedures, including safety rules and regulations


• Must have troubleshooting and problem solving skills


• Ability to work in a dynamic environment with minimal supervision. Organizational skills and Supervisor skills.


• Ability to multi-task and have good time management skills.


• Must have good interpersonal communication and customer service skills.

WORKING CONDITIONS

• Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc)