Plant Quality Manager
Job Summary
To plan, organize and supervise the activities of auditing, in-process and finished product inspection in manufacturing and packaging to ensure regulatory compliance, safety and quality pharmaceutical products.
The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.
Essential Duties And Responsibiliities
• Comprehend, maintain and promote cGMP and SOP compliance in FDA/DEA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance standards.
• Manage and supervise the daily activities of the Plant Quality inspection team on all shifts to ensure oversight of operations process.
• Train, coach and mentor QA personnel, ensuing that training records are complete and accurate.
• Be proficient in all areas of manufacturing and packaging inspection process.
• Write, review and participate in investigations as required. Segregate , quarantine and complete documentation for non-conforming materials.
• Review and approve standard operating procedures, work instructions and policies. Review and approve investigations in the Quality Management System. Review and approve Change Control Forms.
• Help identify and lead on-going initiatives for continuous improvements to PAI’s quality process. Create and revise SOP’s and WI’s. Support validation activities by ensuring that
• protocol requirements are being met.
• Provide timely updates to Quality Management. Work directly with other departments to provide support for manufacturing and packaging activities.
• Support compliance with participating in audit preparations and participate as needed in FDA Inspections and FDA readiness. Participate in agency and customer inspections.
• Contributes to the accomplishment of the objectives and goals of PAI and executive management.
• Perform other related duties as required or assigned.
Education And/Or Experience
Bachelors’ Degree or equivalent experience resulting in broad knowledge of a field related to the job, plus 5 years related experience and/or training, and 5 years related management experience, or equivalent combination of education and experience. This position is responsible for interviewing, hiring and training employees; planning, assigning and directing work; appraising performance, rewarding and discipling employees; addressing complaints and resolving problems.
Knowledge, Skills & Abilities
This position requires the individual be organized, detail-oriented, and self-motivated. The ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Decision making, communication, planning and critical thinking skills are a must. Analytical ability / problem solving, along with accuracy is required. Ability to effectively communicate with top management, partner companies, and executives.
Physical Requirements/Working Conditions
The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g. computers, phones, etc.). Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms. Employee must occasionally lift and/or move up to 50 lbs. frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl along with working in confined spaces. Working knowledge of equipment in maintenance, manufacturing, and high-speed packaging areas. Safety Glass are required on the floor. Gowning requirements while on the floor.
PAI Pharma is a nicotine-free campus , meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine . By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.
PAI is an Equal Opportunity Employer. PAI uses E-Verify.
EEO Employer / Veteran / Disabled
Pharmaceutical Manufacturing
Quality Assurance
Full-time