Senior Specialist, Chemistry QA

Position Overview:

This is a regular, on site full-time position in our New Haven, Connecticut facility.

This individual will also work cross-functionally with senior leadership and team members to support company goals and initiatives, primarily supporting the Chemistry Department in New Haven, CT.

About XingImaging:

XingImaging, a subsidiary of MITRO, is a leading provider of advanced research imaging and radiopharmaceutical services. Our New Haven facility offers a comprehensive range of services, including clinical trial activities and support, advanced imaging, radiotracer manufacturing, and leading imaging analysis services. We are committed to delivering high-quality imaging solutions and accelerating the development of life-saving treatments.

Key Responsibilities:

• Assist in the timely closure of all non-conformances, investigation reports and corrective/preventative actions and in accordance with established guidelines.
• Participate in the oversight of document control systems to ensure all essential documents (batch records, Excel spreadsheets, SOPs) are accurately controlled and distributed properly.
• Issue and review daily production batch records. Track OOS/deviation findings, report noticed trends to supervisor.
• Participate in the development and approval of necessary documentation for the manufacturing of radiopharmaceuticals at the New Haven facility (master batch record, testing standard, validation plan, SOP, WID)
• Review validation raw data (analytical and process) and draft reports.
• Review training documentation
• Maintain current documentation of training, certification and licenses for employees.
• Participate and provide support for internal and sponsor audits as well as vendor audits.
• Provide on-call support to third party manufacturing sites globally
• Other duties as assigned by supervisor.

Qualifications and Requirements:

• Minimum of Bachelor’s degree in science related field
• At least 2 Years experience working in a GMP environment
• General knowledge of radiopharmaceutical regulation
• Support third party manufacturing sites globally which may require off-hour work

PLEASE NOTE:

Please note that since this position is onsite, in the case of epidemic or other health crisis, employee must be willing to take reasonable steps to ensure that bacterial and viral infections are not spread to others including but not limited to temperature checks, vaccinations, exclusion from the office building, and other precautions as required by the building’s landlord.

What We Offer:

• Competitive Salary
• Comprehensive Health Insurance Plan
• Long-Term Disability
• Life Insurance
• Retirement Plan

XingImaging, a Mitro Company provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic information, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person