QC Chemistry Operations Supervisor

NEPHRON SC, LLC•West Columbia, SC

3d•Onsite

About The Position

The QC Chemistry Operations Supervisor will assist in overseeing the day-to-day operations of the QC Chemistry Laboratory in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA and DEA regulations. This role will assist in the implementation of practical process improvements to reduce lead times and improve turn-around times for lab testing. The supervisor will help maintain a flexible organization to allow fast-changing manufacturing priorities to occur with minimum disruption and avoid backlogs. They will ensure the Quality Control group is fully compliant with all cGMP requirements, including adequate maintenance and cleanliness of equipment and laboratories. Additionally, the supervisor will recruit, train, manage, and mentor direct reports and perform other duties as assigned.

Requirements

Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
Detailed oriented with excellent organizational skills.
Effective written and oral communication skills.
Ability to handle multiple projects within limited time frames.
Skills in HPLC, GC, and mass spectroscopy detection technologies.
Excellent communication and technical writing skills.
Expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications.
Ability and willingness to change direction and focus to meet shifting organizational and business demands.
Ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
Ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
Ability to manage a multitude of resources and to be accurate and current with data and information.
Minimum Bachelor’s degree and/or 5 years of experience working in Quality Control Chemistry and/or Research & Development.
Experience with cGMP documentation systems and with implementation of quality control systems.
Strong experience base in product QC testing and release procedures and documentation.

Nice To Haves

Preferred experience in analytical method development, transfer and validation.

Responsibilities

Plans, organizes, and manages resources for sample testing to maintain laboratory workflow and schedule adherence.
Verifies notebooks, raw data, and COA’s before final QC approval.
Verifies data entry in the Laboratory Information Management Systems conform to final product specifications.
Provides management approval for final product release.
Assists in establishing, maintaining, and reporting key performance indicators for the department with respect to daily operations.
Assists in overseeing the QC Chemistry lab operations and assures operations are conducted in accordance with regulatory requirements and expectations.
Responsible for drafting, editing, and approving SOPs related to Analytical Services functions, equipment, documentation, and/or processes.
Assists with the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations.
Develops and approves methods and results including: product specifications; protocols, SOPs, and reports for analytical method validation and stability studies; IQ/OQ/PQ protocols and reports for equipment; master production records.
Directs, performs and resolves out-of-specification investigations and implements corrective and preventative actions.
Day-to-day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters.
Capable of defining strategic objectives for the Analytical Services department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results and processes.