Quality Assurance Manager

Main Function Summary

The Quality Assurance Manager will have overall responsibility for ensuring PhytogenX personnel, processes, and equipment comply with current Good Manufacturing Practices (cGMP) as outlined in 21CFR 210 & 211 and ISO 22716.

Role and Responsibilities

• Liaise with all relevant departments to ascertain current compliance levels
• Provide training and education to team members regarding cGMP
• Ensure that all team members are aware of the procedures to be followed to adhere to compliance requirements
• Oversee the Quality Assurance Department and all related activities including, but not limited to: Change control, Deviation, Nonconformance/CAPA, Customer Complaints, Training, and Standard Operating Procedures (SOPs).
• Organize and conduct internal audits and follow-up on any audit related corrective actions
• Coordinate external regulatory and customer audits and complete requested self-assessments/questionnaires
• Organize, perform, and track the environmental monitoring program of the facility
• Oversee the maintenance and performance of the USP water system
• Organize, perform, and track IQ/OQ/PQ and validation on all production and quality related equipment
• Organize and monitor the equipment calibration program
• Oversee the pest control program
• Maintain and update FDA product registrations and applicable state manufacturing registrations
• Coordinate and delegate compliance related tasks for the Compliance Analyst

 

Experience, Qualifications and Education Requirements

• Bachelor’s degree in Chemistry, Biology, or other scientific discipline with 3-5 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry
• Associates degree in Chemistry, Biology, or other scientific discipline with 5-7 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry
• High School Diploma, or equivalent, with 7+ years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry
• Strong knowledge or understanding of cGMP requirements
• Strong organizational skills and attention to detail
• Ability to multitask and adjust priorities
• Computer skills/MS Office proficiency
• Good communication skills and an ability to work in a fast-paced environment

• Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
• Knowledge of quality systems, industry standards, and safety

Physical Demands

• Prolonged periods of sitting and working at a computer.
• Ability to view computer screens and read documents for extended periods.
• Occasionally lifting objects up to 25 pounds.
• Periodic adjustments to workstation setup and regular breaks to prevent strain.

 

PhytogenX is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, disability, or veteran status. All employment decisions are made based on merit and qualifications.

Employment Type: Full Time
Years Experience: 5 - 10 years
Bonus/Commission: No