QC Lab Manager

Job Description –QC Lab 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, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. 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.

Summary: We are seeking a QC Lab Manager to support our growing QC team, reporting to our QC Manager.

Job Responsibilities

• Oversee all day-to-day QC laboratory operations and related activities.
• 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.
• Responsible for supervision of QC Team during investigation, resolution, and reporting of laboratory non- conformances, OOSs, OOTs, OOEs, and deviations.
• Provide QC Team with developmental feedback throughout the execution of routine operations, as well as new and challenging tasks.
• Develop a disciplined QC Team that adheres to all organization standard operating procedures and good laboratory practices.
• Participate, as well as supervise QC Team members, regarding all QC testing of finished product, product intermediates, and raw materials.
• 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.
• 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
• As this is a position involving occupational exposure to radiation, candidates must not have an aversion to occupational radiation exposure (proper training to be provided).
• Be able to lift heavy objects (up to 70 lbs.)

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

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.)
• 3-5 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
• Experience with MS Word, Excel, project management and analytics software