QC Lab Supervisor

3 weeks ago

Piedmont, United States PL Developments Full time

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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