Quality Specialist II

This is an on-site role 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.

About the role

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.

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 and 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 arise.

Requirements

• 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.
• 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.

Skills

• Strong critical thinking skills, with a close attention to detail and history of good judgment.
• Proven 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.

Benefits

• Competitive remuneration and annual incentive plan bonus.
• Healthcare and a range of employee benefits.
• Employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

Schedule

First Shift (Days)

Environmental Conditions

• Office environment.
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).