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.

Education and/or Experience

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

Language Skills

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

Communication Skills

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

Mathematical Skills

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

Reasoning Ability

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

Computer Skills

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