Position Summary & Responsibilities:
Normal working hours for this role are Monday - Friday from 9:00am - 5:00pm although subject to change.
The QC Microbiology Analyst 1 role is responsible for routine Microbiology testing – this includes the preparation and testing of finished product samples, stability samples, and special test requests per standard operating procedures; culture and manipulation of microbes using aseptic technique and other microbiological testing protocols; and documentation, contributions to Continuous Improvement initiatives, and investigational writing. 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 QC Microbiology laboratory performing testing for Growth Performance, Antimicrobial Neutralization, and Contamination Checks.
-
Quality:
- Ensures all testing is completely documented in an accurate, thorough, and timely manner 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 Microbiology laboratory areas.
- Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
- 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.
- Ensures personal training on current department processes and procedures is maintained.
- Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
-
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.
- Performs additional job-related duties as assigned by management.
Education, Skills, & Experience:
-
Bachelor's degree with 0 years of experience required.
- In lieu of a Bachelor’s Degree, a high school diploma/GED with 4+ years of experience in a regulated laboratory environment OR an Associate’s Degree with 2+ years of experience working in a regulated laboratory environment, also accepted
- Lab experience in Environmental Monitoring and Microbiology highly desired
- BS degree in Biology or Microbiology is preferred
- Technical and scientific knowledge working with microbiological laboratory techniques, testing, and quality principles (GMP/GLP) preferred.
- Experience in the use of software tools for data entry and analysis (LIMS); technical writing skills preferred.
- Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
- Excellent and effective verbal and written communication skills; Teamwork orientation.
- Ability to problem solve/troubleshoot and provide solutions with minimal supervision.
- Ability to proactively identify opportunities for improvements and provide suggestions for improvements.
#biojobs
