Position Description, Functions, Duties and Tasks:

The Technician serves as a resource for the method execution to support the release of Raw Materials, In Process samples, Active Pharmaceutical Ingredients, and Finished Products. The Technician will own the testing and associated data related to Certificate of Testing. The Technician will be knowledgeable of laboratory operations and execute methods per standard operations procedures and escalate any issues to the Chemist.

Functions, Duties, Tasks:

· Assists Chemists in the update of quality systems for analytical testing.

· Provides technical support for continuous improvement in operations by involvement in SOPs and change control systems.

· Assists in the continued training and development of all team members in the areas of safety, cGMP compliance, and on-the-job requirements.

· Reviews and approves SOPs and analytical data.

· Assesses any out-of-specification (OOS) results, determines impact on product, and ensures timely resolution or corrective action, as needed.

· Prepares systems trends utilizing statistical process control.

· Participates in quality audits as needed.

· Performs the following procedures: HPLC, SDS Page, UV, Dissolution Testing, Viscometry, Particle Size, KF, AA, and etc., as needed.

· Perform Wet Chemistry testing.

· Effectively interfaces and communicates with manufacturing personnel to ensure that the analytical needs of the manufacturing facility and operations are met.

· Follows appropriate protocols, SOPs, compendial and analytical methods, and stability protocols for sampling and testing raw materials, bulk powder and finished product.

· Performs basic diagnostic and troubleshooting procedures for laboratory equipment, as needed.

· Performs basic diagnostic and troubleshooting procedures for test methods.

· Prepares controls, standards, solutions, samples, and maintains proper documentation as required by the QC laboratory.

· Assist with receiving samples into QC.

· Prepare samples for testing and shipping to external laboratory.

· May write and revise supporting SOP’s and specifications.

· Maintains appropriate equipment, records, files, and logs according to SOPs and appropriate regulatory requirements.

· Assists in the maintenance of laboratory requirements, including reagents and supplies.

· Performs all activities in a safe and conscientious manner. Maintains a clean environment and assists with periodic lab clean-ups, and moving of equipment and laboratory supplies.

· Data entry into applicable database

· Able to handle change productively and handle other tasks as assigned.

Minimum Qualification (Education, Experience and/or Training, Required Certifications):

· At a minimum an Associate’s degree in science is required or a minimum of 5 years of lab experience

· Familiarity with compendial testing (i.e., USP/NF) strongly desired

· Computer skills (Excel, Word, Empower, SAP)

Additional Preferences:

· B.S. Degree in Chemistry or other scientific-related field strongly preferred

· Preference will be given to candidates with a minimum of two (2) to three (3) years of experience in a QC laboratory, preferably in a manufacturing facility.

· Basic understanding of cGMP for QC laboratories preferred

· Must possess excellent communication and organization skills

· Strong interpersonal and team building skills required; must show desire and ability to work in a team environment

· Must be able to function independently and responsibly with little supervision

· Must be detail-oriented and able to accurately follow protocols and SOPs.

· Flexibility and ability to changing priorities and unforeseen events; excellent time management skills.

Other Information:

• Must be able to work rotating shifts

· Must be able to handle chemicals and biohazardous materials