Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence 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 DescriptionBecome 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.