Quality Assurance Specialist

Job Description:

When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind.

Role Details:

The Quality Specialist serves as subject matter authority for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management.

This individual will participate in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions. Other essential functions include:

• Provides training for department and/or laboratory staff where required.
• Reviews batch records and associated documentation for completeness and accuracy of data.
• Applies department checklists to evaluate content of reports and ensure compliance with reporting criteria.
• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.
• Handles production pre and post line clearances and in-process checks as per GMP requirements.
• Provides support to the department with incoming material inspection
• Participates in risk assessments.
• Leads set up and filing of documents.
• May mentor junior team members in area(s) of expertise.

Education:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 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.

Experience:

• Minimum of 1 year experience in the Quality Assurance function
• Detailed knowledge of applicable GxP and appropriate regional regulations
• Firm knowledge of the clinical trial process
• Good knowledge of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Effectively works independently or in a team environment
• Effective problem solving skills
• Solid interpersonal and time management skills including ability to multitask and prioritize meaningful demands/work load
• Strong computer skills; ability to learn and become proficient with appropriate software
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• Familiarity with enterprise software systems including electronic document control systems, CAPA and training software packages

Knowledge, Skills, Abilities:

• Strong critical thinking skills, with a close attention to detail and history of good judgment
• Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfort learning and using new software programs
• Driven and resourceful, with minimal to moderate direction required
• Proven track record to prioritize work according to urgency and impact