Quality Control Manager
2 months ago
Job Description – Quality Control Manager
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, providing contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. We have recently submitted our first New Drug Application (NDA) to the US FDA. We also operate our own cutting edge cancer research laboratories, developing proprietary, radiotherapeutic medicines.
The company expects rapid growth in the next few years.
Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
Job Responsibilities
- Department leader for all Quality Control operations and related activities.
- Provide regular reports and status updates on QC Department to Site Head(s) and upper management.
- Coordinate with other site leaders to effectively coordinate and execute client and internal projects.
- Schedule and manage laboratory workload, managing utilization and efficiency of laboratory operations.
- Ensure QC laboratory procedures and standards are continuously updated and maintained.
- Establish training programs for new team members and ensure compliance to standard operating procedures, safety, GMP, and other regulatory requirements.
- Develop a disciplined QC Team that adheres to all organization standard operating procedures and good laboratory practices.
- Maintain QC Laboratory calibration records and preventive maintenance schedules for all analytical equipment.
- Provide technical assistance and information to customers, suppliers, and internal departments to ensure product quality.
- Participate in client meetings, site visits, and audits as representative of the QC Department.
- Manage safety and environmental regulations by ensuring that standards, policies, and procedures are adhered to in compliance with organizational, as well as state and local requirements.
- Responsible for establishing the requirements for raw material acceptance from suppliers and continuously monitoring their compliance.
- Participate in customer and regulatory authority audits, when requested by Head of Quality.
- Manage and develop team members by providing feedback, problem solving with and for the team, and conducting any training, performance reviews, and any other important processes alongside Human Resources.
Qualifications/Skills:
- Leadership and collaboration skills
- Strong written and verbal communication skills
- Analytical and critical thinking skills
- Project management skills
- QC process skills
- Computer knowledge and skills
- People management skills
Education and Relevant Experience
- BS in appropriate discipline (STEM)
- Laboratory and QC experience preferred
- Operation of analytical equipment preferred (e.g., HPLC, GC, FTIR, etc.)
- 5+ years’ experience in a QC Managerial role
- Knowledge of local and international regulations relating to QC testing of pharmaceutical products
- Working knowledge of QMS requirements and KPIs
- Working knowledge of LIMS and associated regulatory requirements
- Strong communication skills and proficiency with Microsoft Office product suite.
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