Quality Control Analyst II

Job Title: Clinical and Scientific - Quality Control Analyst II
Work Location: 6201 South Fwy, Fort Worth, TX 76134
Duration: 12 Months Contract

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. 
• 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.

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 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.

All your information will be kept confidential according to EEO guidelines.