What are the responsibilities and job description for the Manager Quality Control position at Particle Sciences Inc, an Agno Pharma Company?
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
Salary : $80,000 - $120,000