QC Chemistry Manager

NEPHRON SC, LLC•West Columbia, SC

7d•Onsite

About The Position

Manage 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. Implement practical process improvements to reduce sample lead times and improve turn-around times for lab testing. Recruit, train, manage, and mentor direct reports. Maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs. Ensure the Quality Control group is fully compliant with all cGMP requirements including adequate maintenance and cleanliness of equipment and laboratories. Ensures the quality of laboratory operations and analytical testing meets or exceeds industry standards. Performs other duties as assigned or apparent.

Requirements

Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives.
Must possess direct experience in analytical method development, transfer and validation.
Must possess a strong experience base in product QC testing and release procedures and documentation.
Must be detailed oriented and have excellent organizational skills.
Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
Must have skills in HPLC, GC, and mass spectroscopy detection technologies.
Must have 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.
The ability and willingness to change direction and focus to meet shifting organizational and business demands.
The ability to create and contribute an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
The ability to manage a multitude of resources and to be accurate and current with data and information.
Minimum Bachelor’s degree and/or 10 years of experience working in Quality Control Chemistry
Experience with cGMP documentation systems and with implementation of quality control systems.

Nice To Haves

Preferred experience in analytical method development, transfer and validation.

Responsibilities

Plans, organizes, and manages resources on projects to assure technical and regulatory quality, budget and schedule adherence.
Lead QC Supervisors to ensure sample release plans and schedule adherence are achieved.
Establish, maintain and report key performance indicators for the department with respect to daily operations.
Actively participate in internal and external audits and follow up on audit findings.
Supports the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations.
Monitors and trends Corrective and Preventive Actions from the conclusion of Laboratory investigations to include Analyst trending, Method tracking, and Product tracking.
Ensure all laboratory equipment is maintained and support troubleshooting. Identify and purchase of new equipment as needed.
Oversee the Operations of the Quality Control Chemistry Laboratory and assure operations are conducted in accordance with regulatory requirements and expectations.
Responsible for drafting SOPs related to Analytical Services functions, equipment, documentation, and/or processes.
Develop and approve 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.
Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results.
Capable of defining strategic objectives for the QC Chemistry department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results.
Day to day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters.