Quality Agreement Specialist at Thermo Fisher Scientific

Pittsburgh, Pennsylvania, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, BiotechnologyIndustries

Requirements

Bachelor’s degree in Quality Assurance, Life Sciences, Engineering, Business Administration or related field
Minimum of 3+ years of experience in quality assurance or regulatory affairs, preferably in the pharmaceutical, biotechnology, or medical device industry
Strong knowledge of regulatory requirements (e.g., FDA, EMA, ISO standards)
Effective communication skills (verbal & written) in English
Basic knowledge of agreement/contracting processes
Excellent negotiation, communication, and interpersonal skills
Detail-oriented with strong organizational and documentation skills
Ability to work independently and handle multiple projects simultaneously
Excellent problem solving, risk assessment and impact analysis abilities
Flexible and able to multi-task and prioritize competing demands/resolve complex issues
Preferred: Certification in Quality Management (e.g., ASQ, Six Sigma)
Preferred: Experience with leading negotiations

Responsibilities

Draft, review, and negotiate quality agreements with external partners and suppliers
Ensure agreements align with regulatory requirements and company standards
Collaborate with legal, procurement, and other relevant departments to finalize agreements
Monitor compliance with quality agreements and regulatory standards
Conduct regular audits and assessments of external partners to ensure adherence to quality agreements
Stay updated on relevant regulations and industry standards
Build and maintain strong relationships with external partners and suppliers
Serve as the primary point of contact for quality-related issues with external partners
Facilitate communication and resolution of quality-related concerns
Coordinate with internal functional departments to ensure various site startup activities align with department priorities and contractual activities within mutually agreed-upon timelines
Maintain accurate and up-to-date records of all quality agreements
Prepare reports on compliance status, audit findings, and corrective actions
Ensure proper documentation of quality-related activities and communications
Drive opportunities for process improvements in quality agreement management
Provide training and guidance to internal teams on quality agreement processes

Skills

Key technologies and capabilities for this role

Quality AgreementsContract NegotiationRegulatory ComplianceAuditsSupplier AssessmentsGDP ComplianceQuality Assurance

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is an onsite position at the Pittsburgh, PA office.

What are the main responsibilities of the Quality Agreement Specialist?

The role involves developing, negotiating, and leading quality agreements with customers, external partners, and suppliers, ensuring compliance with quality standards and regulations, building relationships, managing documentation, and driving process improvements.

What is the work schedule for this role?

The work schedule is standard Monday through Friday in an office environment.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes impactful work, innovative thinking, dedication to doing things the right way with the customer top of mind, and empowering colleagues to realize their full potential in a fast-growing global organization that values passion and unique contributions.

What team is this role part of?

This role is a member of the Quality Assurance Team in the Customer Channels Group (CCG), supporting current business needs and growth to enable GDP capabilities at Independence.

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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