Compliance Specialist III
at Thermo Fisher Scientific
Florence, South Carolina, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 03 Feb, 2025 | Not Specified | 03 Nov, 2024 | 5 year(s) or above | Computer Skills,Memos,Chemistry,Communication Skills,Addition,Biology,Technology Transfer | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
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