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QC Laboratory Manager

2 months ago

Springfield, Massachusetts, United States Evergreen Theragnostics Full time

Job Title: QC Laboratory Manager

About Evergreen Theragnostics

We are a radiopharmaceutical company headquartered in New Jersey, operating in a state-of-the-art facility. Our team is dedicated to developing our own radiopharmaceutical products and providing contract development and manufacturing services for other companies. We also operate cutting-edge cancer research laboratories.

We are a small team where all members support each other in various 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 are possible.

Job Summary:

We are seeking a QC Laboratory Manager to support our growing QC team, reporting to our QC Manager.

Key Responsibilities:

  • Oversee day-to-day QC laboratory operations and related activities.
  • Schedule and manage laboratory workload, ensuring efficient utilization 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.
  • Supervise QC Team during investigation, resolution, and reporting of laboratory non-conformances, OOSs, OOTs, OOEs, and deviations.
  • Provide QC Team with developmental feedback throughout routine operations and new tasks.
  • Develop a disciplined QC Team adhering to all organization standard operating procedures and good laboratory practices.
  • Participate in and supervise 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 adherence to organizational, state, and local requirements.
  • Establish requirements for raw material acceptance from suppliers and continuously monitor their compliance.
  • Participate in customer and regulatory authority audits, as requested by the Head of Quality.
  • This position involves occupational exposure to radiation; candidates must not have an aversion to occupational radiation exposure (proper training will be provided).
  • Ability to lift heavy objects (up to 70 lbs.)

Qualifications and 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 an 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