TSA Quality Compliance Coordinator at Thermo Fisher Scientific

Swedesboro, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Bachelor’s degree required, preferably with a technical or life sciences focus (statistics preferable)
Minimum of 3 years of experience in TSA (Transportation Security Administration) compliance
Extensive knowledge and application of GMP (Good Manufacturing Practices) within pharmaceutical quality systems
Mastery of skills required to read, understand, and adhere to SOPs and policies of a GMP environment
Strong technical writing authorship skills, ability to review reports, and effectively input and express Quality risk management risks
Legally authorized to work in the United States without sponsorship, now or in the future
Ability to pass a comprehensive background check, including drug screening
Physical ability to stand, bend, reach, walk, talk, and exert up to 20 lbs

Responsibilities

Tracks open records in TrackWise, including Deviations, Complaints, CAPAs, observations, and Change Controls to closure
Supports during client and regulatory audits and inspections, as well as with responses to findings and CAPAs as applicable
Serves as TSA Principle Security Officer, including collaborating with TSA personnel on requesting shipping documents and TSA agent walkthroughs of the facility
Handles document creation and control within electronic document system, including making recommendations to draft documents, revising QA documents, and Standard Operating Procedures (SOPs) as required
Oversees employee training curricula in the Learning Management System
Performs other duties as assigned to meet business needs

Skills

Key technologies and capabilities for this role

TrackWiseGMPTSA ComplianceCAPAsDeviationsComplaintsChange ControlsSOPsAuditsInspectionsLearning Management System

Questions & Answers

Common questions about this position

What experience is required for the TSA Quality Compliance Coordinator role?

A Bachelor’s degree is required, preferably with a technical or life sciences focus, along with a minimum of 3 years of experience in TSA compliance and extensive knowledge of GMP in pharmaceutical quality systems.

Is this position remote or on-site?

This is an on-site position in an office environment at the Thermo Fisher Scientific Swedesboro site, with a standard Monday-Friday work schedule.

What are the key responsibilities of this role?

Key duties include tracking open records in TrackWise such as Deviations and CAPAs, supporting audits and inspections, acting as TSA Principle Security Officer, managing document creation and control, and overseeing employee training curricula.

What skills are essential for success in this position?

Candidates need mastery of GMP SOPs and policies, strong technical writing skills for reports and Quality risk management, plus the ability to read, understand, and adhere to procedures in a GMP environment.

What qualifications make a strong candidate for this role?

A strong candidate will have a Bachelor’s degree in a technical or life sciences field, at least 3 years of TSA compliance experience, GMP expertise, and strong technical writing skills; U.S. work authorization without sponsorship and ability to pass a background check including drug screening are required.

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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