Cincinnati Quality Project Lead (PSG) at Thermo Fisher Scientific

Cincinnati, Ohio, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor's degree and 2 years of related work experience in a pharmaceutical work environment
Proven track record to collaborate across the business
Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process
Expertise in handling small and medium technical and/or capital projects
Proven ability to present ideas persuasively and negotiate effectively
Excellent written and oral communication skills both internal and external
Ability to function in a dynamic environment and balance multiple priorities simultaneously
Ability to learn new software and tools quickly
Ability to make decisions and work with minimal to moderate supervision
Ability to write, read/review written documentation for extended periods of time

Responsibilities

Lead and chip in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions
Generate and close CAPAs, Changes, and Deviations including: re-training, SOP revisions, and implementation of new processes within the site
Identify recurring events and trends within site deviations and propose continuous improvement ideas based on findings
Assist in the creation, implementation and maintenance of training curriculum, as well as the launch of learning-based training elements for personnel
Support the site in maintenance of audit readiness
Perform gap analysis to new and existing regulations and standards
Partner cross-functionally to implement process improvements; participates and/or may lead cross functional projects
Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
Recognize, understand and respond to situations requiring further evaluation and report these events to area management

Skills

GMP

CAPA

Deviations

Change Control

SOP

Root Cause Analysis

Audits

Training

Compliance

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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