Job Description

A biotechnology company in the Durham, NC area is looking for a QC Mircrobiolgy Anaylst I to join their growing team. The Analyst will be defining and implementing quality control processes to measure product or service compliance to design specifications. Creating and conducting sampling and testing procedures. Identifying root causes for defects and participates in continuous improvement initiatives. Preparing documentation of findings and making recommendations and developing new processes and tools as needed in order to improve testing execution and impact.

The responsibilities of this position include:

-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 an accurate and timely manner.

-Maintains compliance with SOPs, GLP, GMP, and HSE requirements.

-Prepares for regulatory, customer, and internal audits of microbiology laboratory areas.

-Preparation includes review of logbooks, instrument calibration dates, material expirations, general cleanliness of laboratory area, etc.

-Provides input for laboratory investigations and documents invalid test results in compliance with procedures.

-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.

Must Haves:

• Bachelor's degree (in Biology, Microbiology or Biochemistry or Science related)

Plusses:

• Prior GMP experience
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writin

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