What are the responsibilities and job description for the Quality Investigation Specialists position at Astrix?
Our client is a leading global contract research, development, and manufacturing organization (CDMO) that provides comprehensive services and products spanning the drug development process. They are currently seeking a Quality Investigations Specialist to join their team in Albuquerque, NM.
About the Role
As a Quality Investigations Specialist (QIS), you will play a key role in maintaining quality assurance standards and ensuring compliance with GMP regulations within the pharmaceutical industry. This position focuses on overseeing investigations, promoting continuous improvement, and preparing the facility for regulatory inspections. You may also supervise a team within the Quality Assurance department.
Pay Rate: $25/hour
Location: Albuquerque, New Mexico
Key Responsibilities
- Lead GMP investigations, ensuring compliance with industry standards and regulatory guidelines.
- Collaborate with Quality and Operations teams to ensure facilities and processes are inspection-ready.
- Drive the timely and accurate execution of production activities.
- Oversee commissioning and qualification efforts following the validation lifecycle.
- Conduct QA audits to identify and address opportunities for improvement in training, data integrity, reporting, and manufacturing practices.
- Investigate product complaints, deviations, and process failures, performing root cause analysis and implementing corrective actions.
- Review and approve batch records and oversee the release of products for Manufacturing and Packaging.
Qualifications
- Bachelor’s degree in Science, Chemistry, Biology, or a related field.
- 1–3 years of experience in quality assurance, regulatory affairs, or a related pharmaceutical industry role.
- Strong knowledge of quality assurance, regulatory requirements, and GMP for biological and drug product manufacturing.
- Familiarity with US, European, and Japanese pharmaceutical guidelines and laboratory standards.
- Skilled in performing calculations related to concentration, percentages, and geometric applications.
- Excellent problem-solving abilities and strong communication skills, both written and verbal.
Salary : $22 - $25
