Organogenesis-posted 3 months ago
Full-time • Entry Level
Canton, MA
501-1,000 employees
Merchant Wholesalers, Durable Goods

The QC Analyst II/III performs advanced quality activities in support of product production and releases with moderate/minimal supervision. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst II/ III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. This position requires 2-3 hours of standing per day with frequent stooping and lifting. This position also requires repetitive hand movement e.g., microtomy, use of biopsy punch, and keyboard use for moderate or long periods of time. This position requires flexibility to work some holidays and occasional 3rd shift as needed to support critical final product release.

  • Primary responsibility for the day-to-day activities in the Histology laboratory in support of material and product release testing.
  • Morphological evaluation for release of final product and/or process development samples.
  • Scientific/technical contributor on cross-functional projects related to Histology activities and assay development/optimization.
  • Interact and coordinate with Manufacturing and QA Operations daily.
  • Tracking sample receipt.
  • Execute assigned tasks with minimal supervision.
  • Donated tissue receipt and transfer.
  • Identify and report areas for process improvement.
  • Generate and execute feasibility/validation protocols.
  • Generate trend reports as they relate to quality testing.
  • Work closely with team members to ensure timely release of materials.
  • Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
  • Assist with inter-departmental interactions to ensure customer service needs are satisfied and priorities understood.
  • Identifies and implements issues and opportunities for improvements.
  • Revise/Create SOPs.
  • Minimum requirement; Bachelor's Degree in a Life Science with 3-4 years of experience in a GMP/GLP regulated environment, ASCP Certified.
  • Utilizes advanced technology and scientific methods in the management of assigned technical specialization.
  • Advanced working knowledge of statistics.
  • Proficient in the use and application of quality tools, databases, and process skills.
  • Advanced knowledge of relevant Quality System and SOP procedures.
  • Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO, with an ability to interpret and apply quality and regulatory standards.
  • Advanced working knowledge of tooling, test equipment, laboratory techniques, and CGMP.
  • 401k -- generous employer match with immediate vesting and financial planning resources.
  • Comprehensive Medical, Dental and Vision coverage options effective on day one of employment.
  • Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account.
  • Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options.
  • Paid maternity leave and parental leave for all new parents.
  • Adoption benefits.
  • Education Assistance Policy - $5,000 per year for all employees.
  • Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more.
  • Employee Assistance Program.
  • Generous paid time off including vacation, floating holidays, sick days, and company holidays.
  • Free parking including an electric charging station (Canton and La Jolla).
  • Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint.
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