Supervisor, Quality Control

About the role

The Quality Control Supervisor oversees routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and/or special projects. This role manages a team of Quality Control Chemists and ensures all laboratory operations adhere to cGMPs and regulatory standards.

Responsibilities

• Manage the Quality Control Team
• Perform and supervise analytical testing for various samples
• Ensure compliance with company and governmental standards of safety and quality
• Oversee daily laboratory operations in a safe manner
• Conduct investigations of Out-of-Specification (OOS), deviations, change control management, and Corrective and Preventative Action Plans (CAPAs)
• Supervise and perform pharmaceutical analysis to support drug product manufacturing

Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field
• Minimum 5 years’ experience in a cGMP environment
• Extensive method development and/or validation experience
• Minimum 2 years supervisory experience
• Strong oral and written communication skills
• Expert in cGMP, USP, EP, and FDA regulations
• Technical competence in chromatography (HPLC/UPLC/GC) and other analytical techniques
• Proficient in using computer software, including Microsoft Office Suite
• Strong organizational skills and ability to multi-task
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485

Qualifications

• Education: Bachelor’s degree in Chemistry, Analytical Chemistry, or related field
• Experience: Minimum 5 years’ experience in a cGMP environment, extensive method development and/or validation experience, and minimum 2 years supervisory experience

Skills

• Oral and written communication skills
• Ability to recognize what needs to be done, take action, and accomplish results
• Expert in cGMP, USP, EP, and FDA regulations
• Technical competence including the understanding of theory and interpretation of all lab techniques
• Proficient use of computer software, including Microsoft Office Suite
• Strong organizational skills with the ability to multi-task
• Knowledge of HPLC and GC method development and method validation with extensive experience in other analytical techniques and equipment
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Pay

$88,000-$110,300