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QC Analyst - Microbiology

HonorVet Technologies
Durham, NC Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/7/2025

Position : QC Analyst - Microbiology

Location : 100 Rodolphe Street Durham NC 27712.

Duration : 6 months Temp- to- hire.

Position Summary :

  • The QC Biochemistry Analyst 1 role is responsible for routine Biochemistry testing. The responsibilities of this position include :
  • Testing of raw materials, intermediates, special test requests, stability, and finished product per standard operating procedures.
  • Investigational writing.

Responsibilities : 1. Quality

  • Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
  • Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
  • Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
  • Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
  • Executes laboratory investigations assigned by management in compliance with procedures.
  • Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
  • 2. Documentation / Training

  • Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
  • Ensures personal training is maintained to current department processes and procedures.
  • 3. Safety

  • ppropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
  • 4. Continuous Improvement

  • Participate in continuous improvement activities.
  • 6S : Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
  • 5. Other Duties

  • Performs additional job-related duties as assigned by management.
  • Supplemental Information :

  • This position is in a fast-paced, FDA regulated environment in the Medical Devices / Diagnostics Industry.
  • QC Biochemistry Analyst 1 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.
  • Training and Education :

  • BS / BA in Biology, Chemistry, or Biochemistry with 0 years of relevant experience preferred.
  • high school diploma / GED with a minimum of = 4 years of progressively responsible experience working in a regulated laboratory environment, GMP preferred and / or an associate's degree with a minimum of = 2 years of progressively responsible experience working in a regulated laboratory environment, GMP environment.
  • Experience :

  • Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP / GLP) preferred.
  • Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred.
  • Experience with microbiological testing, sterility and aseptic technique, knowledge of USP and EP / BP method / validation regulations preferred.
  • Knowledge, Skill, and Abilities :

  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
  • Excellent and effective verbal and written communication skills.
  • bility to problem solve / troubleshoot and provide solutions under minimal supervision.
  • Good communication skills; Teamwork orientation. Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
  • ble to assess safety and environmental risks to ensure tasks adhere to HSE Management System.
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