Quality Control Microbiology Analyst II

Job Description

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Fort Worth, TX.

Job Title : Quality Control Microbiology Analyst II (Contract)

Duration : 12 months plus possible extension

40 hours / week, Mon-Fri, 1st shift

Job Description : The Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements.

Key responsibilities include :

• Performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET.
• Provides support to QC Microbiology laboratories.
• Conducts equipment qualifications.
• Supports audits.
• Organizes and assists with Media Fill and Reads.
• Identifies ongoing quality issues, prevents potential problems, and suggests improvements.
• Interprets and evaluates analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary.
• May be responsible for analytical and protocol report writing, as well as standard operating procedures.
• Strictly adheres to Good Documentation Practices (GDP).
• Collaborates with and supports coworkers to enhance the organization's overall capabilities.
• Communicates effectively with production, maintenance, warehouse, and other relevant functions.
• Participates in problem-solving and troubleshooting.
• Supports training needs of team members and works cohesively with the team.
• Coordinates with and supports other departments to ensure smooth workflow execution.
• Ensures the availability of supplies and equipment to meet schedules and carries out tasks as defined by the schedule.