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Pharmaceutical Quality Assurance Officer
2 months ago
Salary: 60,000/yr
Location: Union City, NJ
Employment Type: Direct Hire
Key Responsibilities:
- Ensure adherence to established protocols in manufacturing, materials storage, and laboratory activities.
- Conduct regular GMP inspections independently and in collaboration with Quality Management teams.
- Demonstrate excellent written and verbal communication skills, with the capability to critically analyze and interpret quality incident investigations.
- Utilize knowledge of quality risk management principles to enhance the Quality Management System (QMS) and operational processes.
- Initially assess and manage quality incidents identified on the production floor.
- Review logbook entries in manufacturing and laboratory settings on a daily basis.
Required Knowledge & Skills:
- Comprehensive understanding of FDA-regulated pharmaceutical production and testing processes.
- Adept at identifying issues and effectively communicating them to senior management for further evaluation.
- Ability to navigate challenges across various teams to achieve effective resolutions.
- Lead initiatives that improve site QMS and related functions.
- Proactive approach with strong decision-making, problem-solving, conflict resolution, planning, organization, resource management, and training skills.
- Capable of working autonomously and efficiently on quality-related assignments.
- Able to implement extensive corrective and preventive measures on the production floor, with support from cross-functional teams.
- Quickly identify conflicts or issues and inform management with suggested solutions.
- Effectively relay updates, challenges, projects, and necessary information verbally to diverse audiences.
- Must maintain a "safety-first" mindset due to proximity to radiation.
Basic Qualifications:
- Bachelor's degree in a STEM discipline; equivalent combinations of education and experience may be considered.
- Minimum of 2 years of experience in a GMP environment.
- Familiarity with pharmaceutical production and laboratory operations.
- Work involves time spent in cleanroom environments (aseptic gowning validation required), quality control laboratories, materials storage areas, and office settings.
- Must be able to sit, stand, or walk for up to 50% of the time.
