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About the Role

The QC Chemistry Supervisor is a hands-on role overseeing daily chemistry laboratory operations and personnel. This position coordinates laboratory throughput, compliance, and the stability program, while ensuring adherence to cGLP and regulatory requirements.

Responsibilities

• Review and approve required documentation in a cGMP 503B outsourcing facility.
• Ensure compliance with regulations, policies, and procedures.
• Execute, supervise, and review in-process, development, validation, release, and stability testing.
• Review and approve release/stability specifications and stability protocols.
• Assist in the retrieval and compilation of quality metric data.
• Serve as the point of contact when the Quality Control Manager is unavailable.
• Design and implement personnel schedules to meet production needs and support training.
• Author, review, and/or approve laboratory documents, including protocols, reports, SOPs, test methods, technical documents, and risk assessments.
• Assist in the evaluation of new and existing analytical methods.
• Contribute to, support, and lead the writing of OOS/OOT and nonconformance investigations.
• Drive 5S and Lean projects.
• Support internal and external audits of the facility.
• Ensure adherence to company policies, cGMP, SOPs, and HSE regulations.
• Support junior analysts and chemists with equipment maintenance and troubleshooting.
• Work effectively as a team member to meet departmental objectives and share knowledge.
• Promote and maintain a safe and healthy working environment.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Biology, Chemistry, or a related science.
• 5 to 7 years of pharmaceutical laboratory experience.
• 1-3 years of Supervisory experience preferred.
• Knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and ICH Guidelines.
• Knowledge of statistical tools and trending data analysis.
• Experience with trending and maintaining product stability.
• Experience in writing OOS/OOT and/or deviation investigations.
• Experience in Analytical Quality Control, method development, or a technical support function is desired.
• Proficiency using LIMS and electronic Quality Management Systems.
• Experience with HPLC and chromatographic data software.
• Strong attention to detail and ability to follow standard operating procedures.
• Ability to adapt and respond quickly in a fast-paced environment.
• Ability to work independently.
• Ability to communicate professionally with management, clients, and vendors.
• Excellent organizational, verbal, and written communication skills.
• Must be organized and flexible with an ability to handle multiple work assignments.
• Good conflict resolution abilities.
• Good interpersonal skills to foster a purposeful team culture.

Skills

• Chemistry
• Laboratory Analysis
• Stability Testing
• cGMP Compliance
• Regulatory Requirements
• Documentation Review
• Method Development
• Method Validation
• OOS/OOT Investigations
• Nonconformance Investigations
• 5S
• Lean Projects
• Audits
• HSE Regulations
• Equipment Maintenance
• Troubleshooting
• Teamwork
• Statistical Tools
• Data Analysis
• LIMS
• Electronic Quality Management Systems
• HPLC
• Chromatographic Data Software
• Attention to Detail
• Adaptability
• Independent Work
• Professional Communication
• Organizational Skills
• Verbal Communication
• Written Communication
• Flexibility
• Conflict Resolution
• Interpersonal Skills

Experience Level

• 5-7 years pharmaceutical laboratory experience
• 1-3 years supervisory experience preferred

Education Level

• Bachelor's degree in Biology, Chemistry, or related science