Radio-pharmaceutical Quality Assurance associate

Radio-pharmaceutical Quality Assurance associate
NCM USA BRONX LLCBronx, NY 10454
Qualifications
Bachelor's (Required)Quality assurance: 1 year (Required)
Laboratory: 2 years (Required)
Fluent English (Required)
US work authorization (Required)
CGMP: 1 year (Preferred)
Day Shift (Preferred)
Job details
Job Type
- Full-time, ContractObjectives of Radiopharmaceutical Quality Assurance associate Role
Review the technical and analytical data for the master batch record. Conduct investigations and documentation of OOS / OOT results, CAPA determination and implementation.
Interpret, build upon, and comply with company quality assurance
standards
Carefully maintain nonconformance, deviations and out of specification
through records and tracking systems, including root cause and corrective
actions
Maintain quality and GMP compliance within batch records and quality
control reporting
Perform internal audits to monitor production and quality control
processes
Identify training needs and take action to ensure GMP compliance
Oversee the environmental monitoring and sterility procedures
Plan, execute, and oversee inspection of products to confirm quality
conformance to specifications
Tracking, documenting, and reporting quality levels, environmental and
health and safety goals
Analyze and investigate reported quality issues to ensure closure in
accordance with company guidelines and external regulatory requirements
Monitor procedures and analyze problem logs to identify and report
recurring issues to management
Monitor instrument logs and calibration records to ensure GMP compliance
Skills and Qualifications
Bachelor’s degree
Professional experience as a Quality Auditor
Computer competence, including lab support softwares
Knowledge of quality assurance terminology, methods, and tools
Analytical, problem-solving, and decision-making skills
Job Types: Full-time, Contract
Pay: $55,000.00 - $75,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
COVID-19 considerations:
PPE provided.
Education:
- Bachelor's (Required)
Experience:
- Quality assurance: 1 year (Required)
- CGMP: 1 year (Preferred)
- Laboratory: 2 years (Required)
Language:
- Fluent English (Required)
Shift availability:
- Day Shift (Preferred)
Work Location: One location