Clinical and Scientific - Quality Control Analyst II

Job ID: 26-19338Location: Fort Worth, TXContact: Anuj Sharma1Contact Email: View email address on click.appcast.io Phone: 7325343716Company: MindlanceThe 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

EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”