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Thermo Fisher Scientific · 5 months ago

Sr. QA Specialist - Customer Support

Greenville, North Carolina, USA

Full-time

Onsite

Senior Level

7+ years exp

Thermo Fisher Scientific is a leader in the Pharma Services Group specializing in drug product development and commercialization. The Senior Quality Specialist – Project Lead is responsible for providing technical leadership and quality oversight in a sterile manufacturing environment, ensuring compliance with pharmaceutical regulations and maintaining product quality.

Research

No H1B

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

Qualification

Quality AssuranceRegulatory requirementsProject managementSix SigmaTechnical writingInterpersonal skillsLeadership abilitiesAttention to detailOrganizational skillsEffective communicationNegotiation skills

Required

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

Project management expertise

Strong knowledge of regulatory requirements and quality standards

Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing

Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence is essential

Ability to work independently and to remain firm in complex situations is required in this fast-paced environment

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