Supervisor; QC Laboratory

About the role

The Supervisor assists the QC Manager with the day-to-day operations for one of the assigned QC laboratories, which includes analysis and disposition of commercial materials and environmental samples, as well as troubleshooting, testing assignments, scheduling, training, document review, and special projects.

Responsibilities

• Follow and ensure that the laboratory follows all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc.
• Lead person responsible for maintaining and troubleshooting laboratory equipment.
• Aid in training of laboratory personnel.
• Aid in the day-to-day scheduling, assignment, and coordination of testing/release of materials with Operations and Supply Chain.
• Aid in laboratory investigations (OOS, OOT, NCR, Product Complaint).
• Aid in laboratory documentation review for accuracy and completeness according to GMP, GDP, and data integrity requirements.
• Aid in the review and approval of the Certificate of Analysis for material disposition.
• Work with R&D to develop, improve, and transfer analytical methods for testing.
• Aid in the review and approval of specifications, analytical test methods, process and method validation protocols and reports, change controls, etc.
• Aid in testing materials, as needed.
• Cook with R&D to develop, improve, and transfer analytical methods for testing.
• Aid in the review and approval of specifications, analytical test methods, process and method validation protocols and reports, change controls, etc.
• Cook with R&D to develop, improve, and transfer analytical methods for testing.
• Coordinate and interact with all outside contract laboratories used for testing of samples.
• Ensure that all laboratory equipment is in a calibrated and qualified state as defined and required by SOPs.
• Aid with Metrology related functions, when needed.
• Other responsibilities as assigned by Senior Management.

Requirements

• Bachelor’s degree in a science related field.
• At least 3 years of work experience in a Quality cGMP environment.
• At least 3 years of work experience in a laboratory setting.

Skills, Knowledge, And Abilities

• Knowledge of laboratory chemistry or microbiology, and cGMPs.
• Proficient in Microsoft Word, Excel, PowerPoint, graphs/charts and databases.
• Experienced in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, wet chemistry, and microbial testing.
• Experienced in using analytical software programs, such as Empower.
• Knowledge of laboratory investigations and root cause analysis.
• Skilled in technical writing and data analysis.
• Able to effectively supervise people and give instruction to the department.

Physical Demands

• Sit and stand for long periods of time.
• Frequently reach with arms/hands up to 2 feet.
• Good hand eye coordination.
• Occasionally required to walk and kneel.
• Must be able to lift and/or move up to 50 pounds.
• Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus.
• Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls.
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs.

Work Environment

• Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders.
• Potential to move between production operations sites/areas to complete job functions.
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.

Supervisory Responsibilities

• Responsible for supervising nonunion employees.

Personal Protective Equipment Or Attire Required For Position

• Gowning as required by GMPs and/or SOPs.

Pay

$85,000.00 - $106,000.00