Thermo Fisher Scientific is looking to solve the problem of maintaining full company compliance to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction in a Sterile Manufacturing Environment.
Requirements
- Strong knowledge of regulatory requirements and quality standards
- Professional certifications (e.g., CQA) and training in Six Sigma are beneficial.
- Ability to interpret regulatory requirements and establish systems.
- Knowledge of quality systems and technical writing.
- Experience with quality assurance, quality control, or operations/manufacturing
- Equivalent combinations of experience and education will be considered.
Responsibilities
- Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations.
- Oversees the quality of methods, processes, materials, and products by coordinating and reviewing group operations, providing staff training, and assessing/improving systems and processes.
- Responsible for reviewing and approving procedures, training documents, forms, deviation, and change control of moderate to high complexity.
- Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety, and business risks.
- Act as a technical resource for system support and new product introduction by interpreting regulatory requirements and establishing systems.
- Makes decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering the level of risks related to compliance and product quality.
Other
- Bachelor degree required, preferably in technology, engineering, scientific field or related area required.
- 7+ years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
- Relocation assistance is NOT provided.
