Quality Specialist II

Thermo Fisher Scientific•Detroit, MI

1d•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 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. How will you make an impact? The position's focus is to drive compliance and continual improvement of key QMS elements: audit program, change management, customer notifications, quality systems compliance, document control, and training. This position also supports production partners as needed, to ensure on-time delivery to customers. What will you do? Lead Quality Compliance activities and QMS improvement initiatives, projects, and gap assessments to establish necessary improvements. Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable. Lead and host site’s quality management reviews including issuance and delivery. Own the Detroit Site's internal audit program, responsible for schedule planning and adherence, auditor training, and timely resolution of resulting observations through root cause analysis and the application of effective corrective action Support or lead external audits (e.g. customer, corporate, notified body) 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 Oversee change management program, including customer notification policy Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners Perform QMS document reviews against divisional, corporate, or notified body standards Support the execution of the site's training program Maintain Quality records according to Thermo Fisher Scientific policies and procedures Support 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 with lot release (raw materials and manufactured product) and preparation of certificates of analysis Other projects will be assigned as various business needs arise

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 enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages
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 comfortable with learning and using new software programs
Strong technical writing skills
Proven ability to work in a team and matrixed environment
Driven and resourceful, with minimal to moderate direction required
Proven ability to prioritize work according to urgency and impact, with good time management skills

Nice To Haves

Familiarity with the life sciences industry is desired.
Auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred.

Responsibilities

Lead Quality Compliance activities and QMS improvement initiatives, projects, and gap assessments to establish necessary improvements.
Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable.
Lead and host site’s quality management reviews including issuance and delivery.
Own the Detroit Site's internal audit program, responsible for schedule planning and adherence, auditor training, and timely resolution of resulting observations through root cause analysis and the application of effective corrective action
Support or lead external audits (e.g. customer, corporate, notified body)
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
Oversee change management program, including customer notification policy
Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners
Perform QMS document reviews against divisional, corporate, or notified body standards
Support the execution of the site's training program
Maintain Quality records according to Thermo Fisher Scientific policies and procedures
Support 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 with lot release (raw materials and manufactured product) and preparation of certificates of analysis
Other projects will be assigned as various business needs arise