Manager Quality Control

We are looking for a Quality Control Manager to join the team at Particle Sciences, an Agno Pharma Company! Our team is part of a growing end-to-end Global CDMO with 600+ employees across 4 sites worldwide. Agno Pharma offers API, Intermediates, Drug Product, Drug Implants, Analytical Development, and cGMP manufacturing solutions from pre-clinical through commercialization.

Essential Duties

• Manage the commercial laboratory capabilities at Particle Sciences.
• Maintain and upgrade the GMP laboratory areas for client and internal projects.
• Coordinate scheduling of analytical testing, environmental monitoring, cleaning and qualifications.
• Ensure equipment needed for commercial laboratory testing has been properly qualified for use in the Quality Control laboratory.
• Ensure consumables and other materials needed in the Quality Control laboratory are available and appropriate for GMP testing.
• Write, review and edit SOPs associated with the Quality Control laboratory, and GMP documentation such as Test Methods, Specifications, Method Transfer and Validation
• Oversee all commercial Quality Control laboratory testing and processes.
• Participate in Project Teams approaching and during the commercial Quality Control testing stage.
• Participate as an integral part of planning and execution when commercial Quality Control testing is called for.
• Manage Quality Control personnel as directed by upper management

Knowledge, Skills and Abilities

• BA/BS/MS degree preferably in a scientific field.
• 5+ years of related experience in pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)
• Proficient with common PC based applications and specifically in the use of MS Office
• High-level user skills with MS Word, Excel, PowerPoint, Access, project and Outlook
• Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials
• Knowledge of the design and operation of laboratory equipment under GMPs
• Mechanical/technical ability to learn about the design and operation of new laboratory equipment
• Proven organization, communication, planning and analytical skills
• Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors

Pay: $80,000.00 - $120,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person