Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Become a Quality Specialist III at Thermo Fisher Scientific Inc. and help maintain our operations to the highest industry standards. Work alongside exceptional professionals to make a positive impact on global health, cleanliness, and safety.

Responsibilities

• Establish Standard Operating Procedures (SOP) and perform routine maintenance, including periodic reviews to ensure alignment with regulatory and global requirements.
• Provide training to assure retention of SOPs.
• Conduct audits to determine compliance with quality systems, generate audit reports, identify trends, and establish performance metrics.
• Coordinate vendor qualifications, including questionnaires, quality agreements, and audit schedules.
• Maintain Change Control, Deviation, Out of Specification, Corrective and Preventative Action, Complaint, and investigation report systems.
• Ensure facility compliance status and audit readiness.
• Implement quality compliance and corrective action training programs.
• Train new employees and junior team members on TFS procedures and cGMP regulations.
• Independently lead projects as Quality Assurance Representative with no supervision.
• Stay updated on ICH requirements to ensure compliance of quality systems.
• Ensure all APQRs are accurately generated, reviewed, and submitted.
• Collaborate with site and network resources to coordinate supplier management and address site-specific supplier quality issues.
• Participate in cross-functional teams to successfully implement process control, improvement, and optimization projects.

• Prefer BS degree in Chemistry, Biology, or related scientific field.
• Will consider associate degree (AA/AS) with 5 years relevant experience.

• Ability to comprehend and write complex instructions, correspondence, and memos.
• Effectively present information in one-on-one and small group situations.

• Strong communication skills are essential for client collaboration and technology transfer.

• Proficient in basic arithmetic, including addition, subtraction, multiplication, and division.
• Ability to compute rate, ratio, and percent, and interpret bar graphs.

• Capable of understanding and completing detailed instructions.
• Able to manage complex situations with a variety of variables.

• Proficient in Database software, Design software, and Word Processing software.