Quality Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Discover Impactful Work:

Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide essential quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams. You'll help maintain GMP compliance, investigate quality events, and drive continuous improvement initiatives while working in a collaborative environment focused on delivering life-changing products to our customers.

Under general supervision, provide comprehensive manufacturing technical support and quality assurance oversight to meet good business practices and the requirements of applicable regulatory agencies, supporting one of the following areas: API manufacturing, testing, disposition, quality systems and distribution of bulk drug substance.

Day in the Life:

• Apply technical knowledge to address a broad range of issues to ensure adherence to and compliance with established company policies and procedures, as well as requirements of applicable Regulatory Agencies by working collaboratively with one or more of the following areas: manufacturing, testing, batch disposition, quality systems (Discrepancy/Investigation, change control, CAPA), qualification-validation, and distribution of bulk drug substance. Maintains quality management system associated documentation and all records required to manage the development, production and distribution of the products manufactured at this facility.
• Provide direct support to archival and retrieval of documentation and/or drawings to and from approved storage areas.
• Provide support in the monitoring and analyzing of business process performance measures and notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Ensure that the products are manufactured in compliance with the regulatory and in a GMP compliant manner by reviewing batch records and performing appropriate investigations.
• Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and system issues.
• Assist in writing and revising site SOPs or other procedures as required. Administer, document and maintain the company Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of the company’s Quality Systems and tools, as well as direct actions.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
• Support Site Training in development, delivery and maintenance of Quality training programs (e.g., CAPA process, GMP, etc.).
• Participate in audits and inspections performed by clients and regulatory agencies, as required.
• Participate in the execution and/or administration of corporate Quality System tools such as TrackWise, Documentum, EDMS, etc.
• Provide input to the development of personal performance goals and departmental objectives; collaborate with Management to establish and meet targets and timelines.
• Participate in the design and implementation of department and cross-functional initiatives. Maintain a state of inspection readiness.
• Perform other duties as required.

Keys to Success:

Education

• High School diploma, or equivalent required.
• BS Degree Preferred. Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
• Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous.

Experience

• High school diploma with 3–5 years of experience in pharmaceutical or biological manufacturing, or another regulated industry; or a bachelor’s degree in a technical science or engineering field with 0–3 years of Quality Assurance experience.
• Experience conducting quality investigations and root cause analysis.

Knowledge, Skills, Abilities

• Thorough knowledge of FDA, EMA, and international GMP regulations
• Proven ability to review and approve GMP documentation, batch records, and quality records
• Strong understanding of quality management systems and tools (e.g. CAPA, change control)
• Excellent documentation and technical writing skills
• Proficiency with quality systems software and Microsoft Office applications
• Strong analytical and problem-solving abilities with keen attention to detail
• Outstanding verbal and written communication skills
• Ability to work independently and collaborate effectively across functions
• Knowledge of environmental monitoring and contamination control principles
• Flexibility to work various shifts as needed to support manufacturing operations
• Ability to gown and work in controlled manufacturing environments when required
• Physical capability to stand, walk, and lift up to 25 pounds occasionally
• Sound judgment and decision-making skills
• Commitment to maintaining a quality-focused culture and driving continuous improvement
• Fluency in English required, additional language skills beneficial

 

Excellent Benefits

·         Benefits & Total Rewards | Thermo Fisher Scientific

·         Medical, Dental, & Vision benefits-effective Day 1

·         Paid Time Off & Designated Paid Holidays

·         Retirement Savings Plan

·         Tuition Reimbursement

 

OTHER

·         Relocation assistance is NOT provided

·         Must be legally authorized to work in the United States now or in the future, without sponsorship

·         Must be able to pass a comprehensive background check, which includes a drug screening