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Job Title: Quality Control/Testing: I
Duration: 5+ Months
Location: Durham NC USA 27712
Description of Responsibilities
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
a) Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
b) Ensures review of laboratory testing is done in compliance with SOPs and is completed in an accurate and timely manner.
c) Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
d) Prepares for regulatory, customer, and internal audits of microbiology laboratory areas.
i) Preparation includes review of logbooks, instrument calibration dates, material expirations, general cleanliness of laboratory area, etc.
e) Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
2) Documentation/Training
a) 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.
b) Ensures personal training is maintained to current department processes and procedures.
3) Safety
a) Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
4) Continuous Improvement
a) Participate in continuous improvement activities.
b) 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
a) 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:
1 High School Diploma or GED
0 Vocational/Technical
0 Associate's Degree
0 Bachelor's Degree
0 Master's Degree
0 Doctorate
0 Post Doctorate
0 Professional Certification
Will work experience be accepted in lieu of a degree? 0 Yes 1 No
If yes, number of years of experience accepted in lieu of degree and type:
Bachelor's Degree preferred. High school diploma/GED with 3 years of relevant experience in a regulated environment, GMP preferred.
Experience
1. Prior microbiological lab experience preferred.
2. 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
1 Ability to remain in stationary position, often standing, for prolonged periods.
1 Ability to ascend/descend stairs, ladders, ramps, and the like.
1 Ability to wear PPE correctly most of the day.
0 Ability to operate heavy machinery.
0 Ability to adjust or move objects up to 50 pounds in all directions.