Compliance Specialist III at Thermo Fisher Scientific

Florence, South Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Prefer BS degree in Chemistry, Biology, or related scientific field; will consider associate degree (AA/AS) with 5 years proven experience
Ability to read and comprehend sophisticated instructions, correspondence, and memos
Ability to write complex correspondence
Ability to optimally present information in one-on-one and small group situations to customers, clients, and other employees
Strong communication skills for client teamwork and technology transfer to other sites
Skilled at tact in interpersonal communications
Ability to apply intellectual understanding to carry out and issue detailed instructions
Ability to deal with complex situations with a wide variety of variables
Knowledge of Database software and Word Processing software
Adherence to Good Manufacturing Practices (GMP) Safety Standards and use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

Establishes Standard Operating Procedures (SOPs), performs routine maintenance of SOPs, including periodic reviews to assure alignment with regulatory and global requirements
Provides training when required to assure retention
Audits departments for compliance with quality systems, generating audit reports, identifying trends, and establishing performance of the quality system
Assists with supplier quality tasks (e.g., Approved Supplier List (ASL), vendor qualification and audits review)
Maintains Change Control, Deviation, Out of Specification, Corrective and Preventative Action, Complaint, and Quality Audit systems and their follow-up actions
Supports facility compliance and inspection readiness, including preparation for client and regulatory audits
Delivers training and coaching on TFS procedures, process validation, and cGMP regulations
Independently manages quality assurance projects as a Quality Assurance Representative, ensuring compliance and effective execution
Stays current on ICH, FDA, and global regulatory requirements to maintain compliant quality systems
Collaborates with cross-functional teams (e.g., Research & Development, Logistics, Procurement, Manufacturing, Engineering) on process control, optimization, and continuous improvement initiatives
Provides quality oversight to ensure site compliance with GMP standards for small molecule drug substance manufacturing
Supports quality management systems, including process validation, Annual Product Reviews (APRs), process monitoring, and data integrity, while maintaining inspection readiness
Assists in establishing and maintaining quality systems aligned with industry, regulatory, and customer requirements, supporting the Site Quality Head

Skills

GMP

cGMP

Process Validation

SOPs

Quality Auditing

CAPA

Change Control

Data Integrity

FDA Regulations

ICH Guidelines

Supplier Qualification

Inspection Readiness

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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