QC Lab Supervisor

Monday-Friday 8am-5pm

JOB QUALIFICATIONS:

• Bachelors or Master’s degree in chemistry, biology, or related science field preferred.
• Must have at least 7 years’ experience in analytical laboratory environment within a cGMP facility.
• Strong understanding of process flow for QC laboratory in production setting to effectively plan and organize test schedule; ability to plan and manage multiple projects.
• Expert knowledge in compendial testing, cGMPs, ICH, FDA regulations, and FDA Guidance with strong understanding of cGMP regulations for pharmaceutical and/or food industry.
• Knowledge and experience with analytical method validation, method verification, and method transfer.
• Understanding of equipment qualifications is preferred (IQ, OQ, PQ).
• Strong HPLC and GC troubleshooting skills required.
• Proficient working knowledge in the use of chromatography software, preferably Waters Empower 3.
• Attention to detail required.
• Ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple activities is required.
• Demonstrated leadership skills and excellent verbal and written communication skills are essential. Ability to work successfully in a team environment, and independently as needed, is required.
• Proficient in MS Office including Word, Excel, PowerPoint, and Outlook.
  
  

POSITION RESPONSIBILITIES:

• Review and approve chromatography integrations, calculations, and associated data.
• Review documented data by laboratory personnel.
• Directly supervise the QC laboratory technical and support staff.
• Manage the development and implementation of goals, objectives, procedures and systems pertaining to the QC laboratory, ensuring adherence to company policies and cGMP.
• Establish analytical procedures, methods, and guidelines.
• Select staff and train in laboratory procedures and use of equipment; assign work and evaluates personnel performance.
• Perform analysis of samples and/or specimens using a variety of quantitative and qualitative techniques and instrumentation.
• Supervise raw material testing, in-process testing, bulk testing, stability sample testing and finished product testing to ensure timely release to meet company goals.
• Supervise and participate in the execution of stability protocols, method transfer, and method validations.
• Supervise the development and maintenance of Certificates of Analysis of bulk and finish products.
• Oversee the laboratory equipment calibration program.
• Write laboratory investigations (OOS/LIR) and deviation investigations, as needed. Determine and implement corrective and preventative actions, as needed.
• Develop, implement, and maintain Standard Operating Procedures related to Quality Control laboratory Piedmont, SC.
• All other tasks that might be oriented by the Sr Manager. Corporate Quality Control.
  
  

PHYSICAL REQUIREMENTS:

• Must be able to wear proper gowning and PPE in laboratory and in production areas, as required, to meet GMP and/or OSHA requirements. Must be able to follow all safety requirements as applicable to the area and task.
• Position could be exposed to various work environments such as office, production areas, laboratory, warehouse, etc.
• Some exposure to hazardous chemicals and/or chemical raw materials or ingredients is possible. Must be able to be respirator fit, if needed.
• Light physical activity performing non-strenuous daily activities of an administrative nature including, but not limited to, sitting for greater than 50% of your time, standing and walking for up to 50% of your time.
• Manual dexterity sufficient to reach/handle items and work with the fingers to perform analytical testing (pipet, accurate weighing with spatula, collect swab samples, etc.).
• Use of hands to fingers for typing and other computer activity for up to 75% of your time.
• Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time.
• Ability to frequently lift and/or move up to 20 lbs., and occasionally lift and/or move up to 35 lbs.

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