Quality Specialist I, QA at Thermo Fisher Scientific

Miami, Florida, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, ManufacturingIndustries

Requirements

High School Diploma or equivalent (Bachelor’s degree in a technical field preferred)
Minimum of 3 years experience in a Quality Systems or related role
Knowledge of cGMPs, standards, and regulations such as ISO 9001
Experience with learning management software
Proficiency in MS Office and database software
Strong skills in time management, communication, decision-making, organization, interpersonal, and customer service
Ability to model personal accountability and integrity
Ability to prioritize multiple assignments
Ability to work safely with materials and equipment in environments exposed to fumes and chemicals
Ability to support 24 hours, 5 days a week operation, including overtime/off-shift on-site support
Adherence to GMP safety standards, cleanroom protocols (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair), and various levels of PPE (safety glasses, gowning, gloves, lab coat, ear plugs)

Responsibilities

Support QMS, including document control, record retention, training, change management, and site audits
Manage Site Training Program, including hosting train-the-trainer sessions, performing regular assessments of training effectiveness, building quarterly/annual training programs, using education principles, staying updated on training methods, and collaborating with managers/supervisors on curriculum and records
Support review and approval of master Manufacturing Control Cards (MCCs)
Issue and manage all departmental logbooks at the site
Support evaluation and review of label design requests for compliance
Lead and coordinate New Employee Orientation, including arranging trainer schedules
Participate in site internal/external audits and work with customers to ensure timely closures of audit commitments
Provide Site Support for Learning Management System (LMS), including credit entries, instruction-led course creation, metrics, curricula creation/modification, assignment profile creation, updates to curricula, extension of due dates, and OJT creation/revision/completion updates
Model 4i values (Integrity, Innovation, Intensity, Involvement) and align with Quality Policy for continuous improvement and regulatory compliance
Perform additional duties as assigned by supervisor/manager

Skills

QMS

GMP

Document Control

Record Retention

Training Management

Change Management

Site Audits

Train-the-Trainer

Training Effectiveness Assessment

Manufacturing Control Cards

Label Design Review

New Employee Orientation

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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