Quality Specialist II

Thermo Fisher Scientific • Detroit, MI

6d • Onsite

About The Position

At Thermo Fisher Scientific team, 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. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. Location/Division Specific Information This role is onsite a based at our Detroit, Michigan campus, supporting our Biologicals and Chemicals Division. The Detroit Site maintains ISO 13485 Quality Management System (QMS) certification, manufacturing peptones and other fine chemicals used in bioproduction and culture media. Discover Impactful Work: The Quality Specialist II will have various responsibilities within Quality Assurance to support product release activities, ensuring on-time delivery to customers as well as initiatives for maintaining compliance to the QMS. A day in the Life: Complete Quality record reviews including, but not limited to, batch history records, equipment and calibration documentation, QC records, and shipping records. Support timely delivery of products to customers through lot release (raw materials and manufactured product) and preparation of certificates of analysis Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, supplier questionnaires Maintain Quality records according to Thermo Fisher Scientific policies and procedures Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards, regulatory requirements and policies as applicable. Support the execution of the site's training program Support internal and external audits and ensure compliance with site and industry standards Assist in completion of various QMS requirements, including but not limited to quality management reviews, change management, including document change control, and customer notifications. Other projects will be assigned as various business needs emerge,

Requirements

• A Bachelor's Degree is required. A science major preferred.
• Minimum of 2 years' experience in a Quality Assurance function in an ISO 13485 environment. Familiarity with the life sciences industry is desired.
• Strong critical thinking skills, with a close attention to detail and history of good judgment
• Shown ability to prioritize work according to urgency and impact, with good time management skills
• Driven and resourceful, with minimal to moderate direction required
• Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfortable with learning and using new software programs
• Strong technical writing skills
• Proven ability to work in a team and matrixed environment

Nice To Haves

• Record review and/or auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred but not required.
• Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages.

Responsibilities

• Complete Quality record reviews including, but not limited to, batch history records, equipment and calibration documentation, QC records, and shipping records.
• Support timely delivery of products to customers through lot release (raw materials and manufactured product) and preparation of certificates of analysis
• Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, supplier questionnaires
• Maintain Quality records according to Thermo Fisher Scientific policies and procedures
• Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards, regulatory requirements and policies as applicable.
• Support the execution of the site's training program
• Support internal and external audits and ensure compliance with site and industry standards
• Assist in completion of various QMS requirements, including but not limited to quality management reviews, change management, including document change control, and customer notifications.
• Other projects will be assigned as various business needs emerge

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees