QC Microbiology Analyst 1

Company : HonorVet Technologies

Job Title: QC Microbiology Analyst 1
Job Location: 100 Rodolphe Street Durham NC 27712
Job Duration: 12+Months contact
Shift: Mon-Friday 9-5/8-4 flexibility

Job Description

• The QC Microbiology Analyst 1 role is responsible for routine Microbiology testing. The responsibilities of this position include:
• Testing of finished product samples, special test requests, and stability per standard operating procedures.
• Preparation and maintenance of microbial cultures and microbial manipulation for testing using microbiological instrumentation, aseptic technique, and the proper PPE.
• Investigational writing.

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 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.

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

• Appropriately 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 Data
This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, Contamination Checks, and other testing duties.

Training and Education

• BS in Microbiology, Biology, Biochemistry, or related life science.

OR

• in lieu of a bachelor's degree, a high school diploma/GED with 4 years of relevant experience in a regulated environment, GMP preferred, OR an associate's degree with 2 years of relevant experience working in a regulated environment, GMP preferred.

Experience

• BS with 0 years of relevant experience required.
• Prior microbiological lab experience preferred.
• Experience with sterile technique preferred.

Knowledge, Skills, and Abilities

• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
• Excellent and effective verbal and written communication skills.
• Theoretical knowledge of relevant laboratory techniques and quality principles.
• Knowledge of software tools for data entry and analysis.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Teamwork orientation and demonstrated history of taking initiative to find and make improvements.
• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
• Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.
• Physical Requirements:
• Ability to remain in stationary position, often standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.

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