Quality Control Analyst

About the Organization Associates of Cape Cod, Inc. (ACC) Your Endotoxin Experts! Manufactures bacterial endotoxin and beta-glucan detection products. The Company offers enzymes, muco-polysaccharides, monoclonal antibodies and glyco-conjugates, endoglycosidases, and exo-glycosidases, as well as 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, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements.

Learns and executes defined QC tasks efficiently and consistently. Results are compared to specifications and documented in a timely manner. Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

• Technical Expertise
  • Demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
    • Test methods may include (but are not limited to):
      • Environmental Monitoring
        • Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
        • Perform Growth Promotion testing of microbiological media
        • Perform Plate reading, streaking, gram staining, and microbial
        • Perform Sterility Testing
      • Product Release and Stability Testing
        • Perform routine Quality Control testing of raw materials, in-process and final products in accordance with SOP’s.
        • Perform endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
        • Perform Karl Fisher Moisture, pH, and container closure, testing
        • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
        • Prepare and review Certificates of Analysis
        • Formulates and tests in process solutions to determine final product ratios
      • Raw Materials
        • Receiving Inspection of all Raw Materials
        • Testing Raw Materials (in house/contract lab)
    • Data Analysis
      • Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete.
    • General Lab Support
      • Test sample management and handling, maintenance of lab equipment and log sheets, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
      • Participate in safety, customer, and quality audits including answering questions during tours.
      • Maintain log sheets related to equipment and inventory, may assist in ordering of materials, reagents and supplies
      • Preparation of glassware for Laboratory use
      • Management/Handling of Hazardous Waste
  • Problem Solving/Decision Making
    • Collaborate with Supervisor to implement corrective actions in response to assay and/or instrument problems.
    • Contribute to discussions with the team to meet group goals
    • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and method performance issues. Alert Supervisor and make detailed observations in support of investigations.
  • Planning
    • Plans execution of individual tests and activities in conjunction with Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (i.e. discussing schedule conflicts with Supervisor, ensuring all material is available for…