Quality Control Analyst III

About the Organization:
Associates of Cape Cod, Inc. (ACC) – Your Endotoxin Experts! ACC manufactures bacterial endotoxin and beta‑glucan detection products, including enzymes, monoclonal antibodies, glyco‑conjugates, endoglycosidases, exo‑glycosidases, and limulus amebocyte lysate products. ACC serves customers worldwide.

Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, FDA and other regulatory guidelines, and approved license requirements. Results are compared to specifications and documented.

Analyst is technically independent and has mastered fundamental quality control concepts as well as specialized technologies. Independently coordinates activities, carries out projects with minimal supervision, and displays initiative and technical commitment for study design. Provides written and/or oral presentations of work with minimal input from supervisor and offers guidance and training to other staff.

• Technical Expertise
  • Proficient performance of test methods, data analysis, and laboratory support per approved procedures.
    • Environmental Monitoring
      • Sample collection and testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets, and critical utilities including water systems.
      • Growth Promotion testing of microbiological media.
      • Plate reading, streaking, gram staining, and microbial .
      • Sterility Testing.
    • Product Release and Stability Testing
      • Routine Quality Control testing of raw materials, in‑process, and final products per SOPs.
      • Complex testing per written protocols.
      • Endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic).
      • Karl Fisher titration for moisture, pH determination, and container closure testing.
      • Standardization of Control Standard Endotoxin to Reference Standard Endotoxin.
      • Preparation and review of Certificates of Analysis.
      • Formula development and feasibility testing for final product ratios.
    • Raw Materials
      • Receiving inspection of raw materials.
      • Testing of raw materials.
  • Data Analysis
    • Perform calculations, interpret results, and record data accurately and completely.
  • General Lab Support
    • Sample management, equipment maintenance, logbook upkeep, ordering materials and reagents, and maintaining lab cleanliness and safety.
    • Participation in safety, customer, and quality audits.
    • Coordinating intra‑ and inter‑departmental activities.
    • Preparation of glassware and hazardous waste handling.
• Problem Solving / Decision Making
  • Technically independent, contributes to interpretation of results, and designs follow‑up studies.
  • Proposes corrective actions and investigative troubleshooting to improve compliance, efficiency, and cost.
  • Leads discussions with team and communicates technical issues inter‑departmentally.
  • Review departmental data for compliance, identifies trends, and assists in investigations.
  • Represents QC at cross‑functional meetings.
• Planning
  • Plans sequencing of tests and activities, communicates plan to supervisor.
  • Prepares reports independently and submits for approval.
  • Prepares metrics reports, including statistical analysis.
  • Prepares training plans as required.
• Supervision
  • Receives overall direction from supervisor and carries out tests without supervision.
  • May supervise junior staff and provide training.
• Perform other additional job‑related duties as required.

• Organizational skills
• Time management skills
• General laboratory skills
• Detail oriented, proficiency in aseptic and laboratory technique
• Ability to work independently and in cross‑functional teams in a fast‑paced laboratory environment
• Working knowledge of cGMP, ISO 13485 quality system requirements, and quality control principles
• Required to pass a pipetting proficiency training and certification course
• Required to pass LAL training and certification

• Minimum of a B.S. degree in a relevant scientific…