QC Lab Coordinator

PAI Holdings LLC•Greenville, SC

About The Position

Responsible for performance of routine laboratory functions and administrative tasks per applicable procedures to support QC laboratory goals, while maintaining GMP and DEA regulatory compliance. Provide support to the stability and reserve sample programs. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

Requirements

This position requires the individual to be organized, detail-oriented, and self-motivated.
Experience with Microsoft Office Suite is required.
Decision making, communication, planning and critical thinking skills are a must.
Analytical ability / problem solving, along with accuracy is required.
Ability to effectively communicate with employees.
High school diploma or equivalent.
At least two years related experience, preferably in a laboratory environment.

Responsibilities

Receive samples into the laboratory and log samples into the Laboratory Information Management System (LIMS). Distribute samples to laboratory analysts.
Issue Controlled Worksheets to laboratory analysts.
Maintain controlled substance tracking records/inventory for the laboratories per applicable procedures. Prepare the proper documentation for transfer of controlled substances from the 201 facility to the 1700 facility, per applicable procedures.
Assist DEA department with inventory and destruction of controlled substance material and samples per applicable procedures and regulations.
Receive laboratory supplies, standards, and reagents; assign and label containers within expiration dates and other applicable information; store in appropriate lab areas. Update inventory databases or column logs accordingly.
Maintain USP reference standard inventory; order laboratory supplies, standards, and reagents as specified by laboratory staff. Ensure correct grade of materials is ordered at best possible price.
Perform expiration date audits of reagents, reference standards, USP standards, solutions, etc. Ensure all chemicals reagents, solutions, and USP standard in the lab are current.
Coordinate sending laboratory samples to contract labs as needed. Obtain quotes for specific testing and ensure pricing is correct, when required. Record results in lab notebook when required. Notify accounts payable that PO is acceptable to pay, when results are received.
Assist in the disposal and/or destruction of tested and released laboratory samples.
Store and manage stability samples for each product in the stability chamber(s) under appropriate storage conditions and orientations per the approved stability protocol, and verify proper staging, pulling, labeling, and delivery of samples to the appropriate testing laboratory.
Assist with the management of reserve samples for each product, including staging, maintaining, inspecting, and removing as needed.
Assist with laboratory organization, entering data into systems, and other duties as instructed by management.
Accountable for the accuracy and timeliness of all assigned projects, submitted POs files, reports, record keeping, and attention to detail. For following applicable Standard Operating Procedures, including all safety procedures and policies. For working safely in an effective work team.