MANAGER QUALITY CONTROL LABORATORY

FORMULATED Solutions LLC•Largo, FL

About The Position

The Quality Control Laboratory Manager will lead and manage the Quality Control Laboratory to ensure all analytical testing, material disposition, and laboratory operations are performed accurately, efficiently, and in full compliance with regulatory and company standards. This role is responsible for maintaining the integrity of testing processes, supporting product quality and safety, driving continuous improvement, and developing laboratory personnel while collaborating cross-functionally to support manufacturing and analytical development activities.

Requirements

IN-DEPTH KNOWLEDGE OF THE TESTING REQUIRED FOR ALL INCOMING MATERIALS, IN-PROCESS SAMPLES AND FINISHED PRODUCT TESTING.
IN-DEPTH KNOWLEDGE OF PHARMACEUTICAL MANUFACTURING AS WELL AS GLP’S, GMP’S AND COMPENDIAL TESTING REQUIREMENTS.
STRONG WORKING KNOWLEDGE OF ANALYTICAL PROCEDURES.
EXTENSIVE COMPUTER AND COMMUNICATION SKILLS, BOTH VERBAL AND WRITTEN.
MUST BE ABLE TO WORK IN A FAST-PACED ENVIRONMENT AND HAVE A POSITIVE ATTITUDE.
MUST HAVE SUPERVISORY EXPERIENCE AND BE WILLING TO MENTOR DIRECT REPORTS TO SUPPORT CAREER GROWTH AND SUCCESSION PLANNING.
Bachelor’s degree in Chemistry or other life sciences discipline.
At least five years direct analytical lab experience in an FDA regulated pharmaceutical or medical device industry.

Responsibilities

Oversee daily operation and scheduling of Quality Control Laboratory, including all analytical activities.
Supervise and provide training and mentoring to direct and indirect reports within the Quality Control Laboratory.
Ensure completion of all testing activities for raw materials, in-process samples, finished product samples, cleaning validation samples as well as stability samples in a timely and appropriate manner.
Disposition of all raw materials, in-process samples, finished goods materials as well as cleaning validation results.
Responsible for overseeing all events, investigations, deviations, and the implementation of appropriate corrective actions.
Ensure compliance of Test Methods and relevant Quality Laboratory standard operating procedures.
Develop Incoming Inspection Reports for all raw materials, ensuring they meet compendial requirements.
Collaborate with Analytical Research and Development (AR&D) to develop, review, implement and validate in-house analytical test methods.
Coordinate and collaborate with AR&D to facilitate analytical method transfer activities.
Manage raw materials and retain sample program programs.
Manage the Stability Sample testing program, ensuring all testing is performed in the appropriate time frame and in compliance with existing analytical methods and specifications.
Oversee the metrology functions for the laboratory, ensuring that all analytical equipment is qualified, maintained, and calibrated.
Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP’s and other approved test methods.
Accurately records raw data, analyzes data, as well as calculates and interprets the results.
Maintains records necessary for Quality Control, including charts, statistical analyses and reports.
Participate in other activities as assigned by the Vice President of Quality.