Assoc QA Specialist

Work Schedule

Environmental Conditions

Job Description

Join us as Associate Quality Assurance Specialist - And ensure the highest standards of quality and compliance in our clinical research activities.

What Youll 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:
Bachelors degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelors 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 drivers 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. Youll 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 tomorrows breakthrough.