Senior Quality Assurance Specialist

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

• Participate in the development, revision, and implementation of QA SOPs, tools and systems to ensure conformance to applicable to regulatory standards including, but not limited to, 21 CFR Parts 210, 211, 820 and 11, and applicable ICH Guidelines.
• Maintain current knowledge of regulations and elaborate best practices auditing guideline
• Oversee the environmental monitoring program including generation of documentation such as risk assessments and trending reports.
• Environmental Monitoring (EM) of pharmaceutical cleanrooms and the associated spaces on a daily basis according to cGMP and company requirements.
• Sampling and proper documentation for testing of facility systems for microbial analysis.
• Provide technical guidance to operations and other support areas regarding EM and sterility assurance matters.
• Provide technical support for EM initiatives involving viable, non-viable and personnel monitoring. Manage procedural revisions if needed.
• Provide support during root cause investigations of EM excursions.
• Support and monitor development and execution of qualification and validation studies and author risk assessments as appropriate.
• Support and monitor development and execution of equipment and instrument qualifications (IQ, OQ, and PQ)

Knowledge, Skills and Abilities

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

· Has 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

· 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

Knowledge, Skills and Abilities

• BA/BS/MS degree preferably in a scientific field.
• 4+ 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