Quality Assurance Manager

6 days ago

Springfield, Massachusetts, United States Evergreen Theragnostics Full time
About Evergreen Theragnostics

We are a radiopharmaceutical company headquartered in New Jersey, operating in a state-of-the-art facility. Our team provides contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and diagnostics. We also conduct cutting-edge cancer research, developing proprietary medicines.

We are a small, collaborative team where members support each other in various activities. We are seeking motivated individuals who can take on new challenges and contribute to our growth.

Job Summary

We are looking for a Quality Control Supervisor to manage our QC laboratory operations and team for the overnight shift. The successful candidate will oversee and perform QC testing, prepare stability records, and develop analytical methods.

Key Responsibilities
  • Manage QC laboratory operations and team for the overnight shift
  • Oversee and perform QC testing, prepare stability records, and summaries
  • Develop, train, and transfer analytical methods to and from QC and contract manufacturers
  • Modify and validate analytical procedures to meet QC needs
  • Conduct quality QC chemical tests for release of batches for patient use
  • Participate and lead special projects and department meetings
  • Execute special projects on analytical and instrument problem solving
  • Perform timely radioactive and microbiological QC and record quality of product
  • Adapt, maintain, and operate analytical instrumentation
  • Ensure a clean, safe, and compliant work environment
  • Conduct radiation safety duties conforming to regulations
  • Report monthly on supplies for QC orders
  • Contribute to industrial, R&D qualification, and validation activities
  • Lead laboratory investigations and root-cause analyses
Requirements
  • At least 5 years GMP QC laboratory experience, including people leadership experience
  • Excellent organizational skills
  • Bachelor's Degree in Chemistry or Biochemistry
  • Experience using analytical techniques, such as HPLC and rTLC
  • Excellent oral and written communication, organizational, and problem-solving skills
  • Ability to convey complex ideas in a simple manner
  • Knowledge of analytical methods currently used for testing, release, and stability of sterile pharmaceutical products
  • Team-oriented mindset and ability to work with cross-functional teams
  • Fluent in Microsoft Word and experienced in working with LIMS

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