Quality Assurance Manager

4 weeks ago

Springfield, New Jersey, 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 and develop proprietary medicines.

We are a small, dynamic team that supports each other in various activities. We are looking for motivated team members who are excited to help build the company and take on new challenges. Partial equity-based compensation packages are possible.

Job Responsibilities

We are seeking a Quality Control Supervisor to manage our QC laboratory operations and team for the overnight shift. The ideal candidate will have at least 5 years of GMP QC laboratory experience, including people leadership experience.

  • Manage QC laboratory operations and team for the overnight shift.
  • Oversee and perform QC testing, prepare and maintain stability records and summaries.
  • Develop, train, and transfer methods to and from QC and contract manufacturers as assigned.
  • Modify and validate analytical procedures to meet QC's needs.
  • Perform design and development of experimental protocols, SOP's, etc., consistent with cGMP/GLP.
  • Conduct all quality QC chemical tests for release of batches for patient use.
  • Participate and lead special projects and department meetings via input, feedback, and execution of assigned tasks.
  • 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 the work environment is clean, safe, and in compliance with safety and pharmaceutical regulations.
  • Conduct radiation safety duties conforming to regulations.
  • Report monthly on supplies for QC orders involving devices and reagents.
  • Contribute to industrial, R&D qualification and validation activities and support routine maintenance.
  • Lead laboratory investigations and root-cause analyses.
  • Prepare chemical reagents for manufacturing and QC.
Essential Qualifications
  • At least 5 years GMP QC laboratory experience required, including people leadership experience.
  • Excellent organizational skills required.
  • Bachelor's Degree in Chemistry or Biochemistry required.
  • Experience using analytical techniques, such as High-Performance Liquid Chromatography (HPLC) and radio-Thin Layer Chromatography (rTLC).
  • Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
  • Ability to convey complex ideas in a simple manner to management and customers, exercise independent judgement during method development/transfer processes.
  • Knowledge of analytical methods currently used for testing, release, and stability of sterile pharmaceutical products.
  • Team-oriented mindset and demonstrates ability to work easily with cross-functional teams.
  • Fluent in Microsoft Word and experienced in working with laboratory information management systems (LIMS).

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