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Quality Control Operations Supervisor
|West Columbia, South Carolina - United States
$45,000.00 - $60,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
- 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.
- Assist in the implement practical process improvements to reduce lead times and improve turn-around times for lab testing.
- Help 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.
- Performs other duties as assigned or apparent.
- Plans, organizes, and manages resources on projects to assure technical and regulatory, budget and schedule adherence.
- Calibrate, maintain and troubleshoot analytical equipment, identify and purchase of new equipment as needed.
- Assist in overseeing the QC Chemistry lab operations 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.
- Direct, perform and resolve out-of-specification investigations and implement corrective and preventative actions
Knowledge, Skills & Abilities:
- 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.
- Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
- Preferred 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.
- The ability and willingness to change direction and focus to meet shifting organizational and business demands.
- The ability to create and contribute 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.
- Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.
- 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.
University - Bachelor's Degree/3-4 Year Degree