Compliance Specialist III

at  Thermo Fisher Scientific

Florence, South Carolina, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate03 Feb, 2025Not Specified03 Nov, 20245 year(s) or aboveComputer Skills,Memos,Chemistry,Communication Skills,Addition,Biology,Technology TransferNoNo
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Description:

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.

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.

COMPUTER SKILLS

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

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.


REQUIREMENT SUMMARY

Min:5.0Max:10.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Clinical Pharmacy

BSc

Biology, Chemistry

Proficient

1

Florence, SC, USA