Join us as Associate Quality Assurance Specialist - And ensure the highest standards of quality and compliance in our clinical research activities.
What You’ll Do:
- Conduct audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis or Total Quality Management.
- Assist in client and regulatory inspections/audits and follows up on assigned audit issues and corrective action.
- Provide training for department and/or laboratory staff where required.
- Evaluate acceptability of data based on criteria set forth in SOPs and methods.
- Review data sample result tables and analytical reports for completeness and accuracy of data.
- Utilize department checklists to evaluate content of reports and compliance with reporting criteria.
- Verify accuracy of analytical results and sample identification, inventories and submits data to archives. Assists the team from an administrative perspective on quality investigations and Global Clinical Supplies (GCS) services.
- Scan, photocopy, files and ensure that records are kept up to date.
- Participate in inter-departmental meetings and contributing to policymaking decisions.
- Assist with pre and post line clearances as per GMP requirements.
- Provide support to the department with incoming material inspection as per GMP requirements. Review batch records and other GMP documentation with oversight.
Required Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelor’s degree.
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Required Knowledge, Skills and Abilities:
- Introductory knowledge of applicable GxP and appropriate regional regulations
- Working knowledge of SOPs and WPDs
- Strong oral and written communication skills (including appropriate use of medical and scientific terminology)
- Good attention to detail
- Able to work independently or in a team environment
- Good problem-solving skills
- Maturity to handle sensitive and confidential information appropriately
- Good organizational and time management skills
- Basic computer skills: ability to learn and become proficient with appropriate software
- Demonstrated flexibility and adaptability
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthrough.
