- The Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements.
location: Fort Worth, Texas
job type: Contract
salary: $30 - 35 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- 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.
qualifications:
- Education: Bachelor's degree in Microbiology or a related scientific field.
- Experience: 2-4 years of hands-on QC Microbiology experience in a cGMP pharmaceutical or biotech environment.
- Technical Skills: Proven proficiency in Aseptic Technique and core testing, including Sterility, Endotoxin (LAL), and Bioburden.
- Compliance: Strong working knowledge of cGMP/GLP regulations and Good Documentation Practices (GDP).
- Soft Skills: Excellent technical writing skills for SOPs/reports and effective cross-functional communication.
skills: Microbiology, Good Laboratory Practices (GLP), SOP Development, Good Documentation Practices (GDP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.