Job Description
Job Description
Title: QC Microbiology Analyst 1
Location: Durham, NC 27712
Duration: 06 Months
1st shift: M-F 9 AM – 5 PM
Position Summary
The QC Microbiology Analyst 1 role is responsible for microbiological testing.
The responsibilities of this position include:
- Testing of finished product samples, stability samples, and special test requests of multiple products per standard operating procedures.
- Preparation and manipulation of microbial cultures and stocks using aseptic technique.
- Investigational writing.
Primary Duties
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.
Qualifications
Training and Education
- Preferred a BS in Microbiology, Biology, Biochemistry, or related life science.
Check the highest-level education required (must be job-related). Identify the discipline, where applicable:
- High School Diploma or GED
- Bachelor’s Degree preferred. High school diploma/GED with 3 years of relevant experience in a regulated environment, GMP preferred.
Experience
- 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.
Working Conditions and Physical Requirements
Check if applicable
- 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.