Sr. QA Specialist - Customer Support at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor degree required, preferably in technology, engineering, scientific field or related area
Minimum 5 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required (equivalent combinations of training and meaningful work experience may be considered if at least a bachelor degree is acquired)
Project management expertise
Strong knowledge of regulatory requirements and quality standards
Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing
Professional certifications (e.g., CQA) and training in Six Sigma are beneficial
Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence
Ability to work independently and remain firm in complex situations in a fast-paced environment
Physical requirements: ordinary ambulatory skills and physical coordination to move about office locations; ability to stand, walk, stoop, kneel, crouch for prolonged periods; lift/carry/move light to medium weights (10-35 pounds); arm, hand, finger dexterity; visual acuity for keyboard/computer use and reading; ability to sit, reach, talk, and hear for prolonged periods

Responsibilities

Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations
Oversees the quality of methods, processes, materials, and products by coordinating and reviewing group operations, providing staff training, and assessing/improving systems and processes
Reviews and approves procedures, training documents, forms, deviations, and change controls of moderate to high complexity
Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety, and business risks
Acts as a technical resource for system support and new product introduction by interpreting regulatory requirements and establishing systems
Makes decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering the level of risks related to compliance and product quality
Provides technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction

Skills

Key technologies and capabilities for this role

Quality AssuranceGMP ComplianceRegulatory ComplianceRisk AssessmentChange ControlDeviation ManagementProcedure ReviewStaff TrainingProject LeadershipSterile Manufacturing

Questions & Answers

Common questions about this position

What is the salary for this Senior QA Specialist position?

This information is not specified in the job description.

Is this Senior QA Specialist role remote or office-based?

This information is not specified in the job description.

What education and experience are required for this role?

A Bachelor degree is required, preferably in technology, engineering, scientific field or related area, with minimum 5 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing.

What key skills are needed for the Senior QA Specialist position?

Project management expertise, strong knowledge of regulatory requirements and quality standards, excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing are required.

What makes a strong candidate for this Senior QA Specialist role?

Candidates with a Bachelor’s degree in a relevant field, at least 5 years in QA/QC or manufacturing, project management expertise, regulatory knowledge, leadership skills, and professional certifications like CQA stand out.

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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