Quality Control Analyst II

Techtrueup; Fort Worth (TX); Vor Ort; USD 52.000 - 56.000; Vollzeit

Zusammenfassung

Techtrueup is seeking a Clinical and Scientific - Quality Control Analyst II for a 12-month contract at our Fort Worth, TX location. The role focuses on maintaining high laboratory standards and regulatory compliance.

The incumbent will perform microbiological validations (Bioburden, Endotoxin, Sterility, PET), support QC Microbiology labs, conduct equipment qualifications, and ensure GDP compliance while collaborating across departments to sustain quality and efficiency.

Qualifikationen

• 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.

Aufgaben

• 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).
• 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.

Kenntnisse

Pharma regulations

Quality control

Documentation

Team collaboration

Ausbildung

Bachelor’s Degree or equivalent

Jobbeschreibung

Job Description

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.

Compensation:

$25-$25