Quality Control Analyst II

Job Title:  Quality Control Analyst II - Microbiology
Job Location - Fort Worth, TX
Duration - 12 months

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

• Performing microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET.
• Providing support to QC Microbiology laboratories.
• Conducting equipment qualifications.
• Organizing and assisting with Media Fill and Reads.
• Identifying ongoing quality issues, preventing potential problems, and suggesting improvements.
• Interpreting and evaluating analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary.
• Potentially responsible for analytical and protocol report writing, as well as standard operating procedures.
• Strictly adhering to Good Documentation Practices (GDP).
• Collaborating with and supporting coworkers to enhance the organization's overall capabilities.
• Communicating effectively with production, maintenance, warehouse, and other relevant functions.
• Participating in problem-solving and troubleshooting.
• Supporting training needs of team members and working cohesively with the team.
• Coordinating with and supporting other departments to ensure smooth workflow execution.
• Ensuring the availability of supplies and equipment to meet schedules and carrying out tasks as defined by the schedule.

Qualifications

• Bachelor’s Degree or equivalent years of related experience (or high school 8 yrs; Assoc. 4 yrs).
• The ability to fluently read, write, understand, and communicate in English.

Desired Competencies

• Strong knowledge of pharmaceutical regulatory requirements.
• Excellent communication skills, in both verbal and written form.
• Highly attentive to details and comfortable speaking up.
• Self-starter with the ability to follow up on and complete multiple projects simultaneously with little direction.
• Able to work overtime and flexible work hours to meet department goals.