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Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Title: Quality Specialist II

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Division/Site Specific Information

Position is based Manati, Puerto Rico. As part of the Quality System Team you will assure the quality of current and future products and satisfy the very high expectations of our customers in pharmaceutical manufacturing. You will achieve this by collaborating closely with other functions and departments to determine solutions for diverse challenges as well as independently striving for continual improvement of Quality Management System processes.

A Day in the Life:

The Quality Specialist II is a vital role within our organization, responsible for maintaining the Quality Systems in compliance with Current Good Manufacturing Practices (cGMPs), Global Regulatory requirements, company policies, procedures, and all other applicable regulations and guidelines. The primary focus areas for this role include:

+ Managing the Change Control Program.

+ Support in Quality Regulatory Inspections.

+ Managing Annual Product Reviews.

+ Implementing Global Site procedures.

+ Responding to Clients regulatory requests.

+ Offer direction for the vital Qualifications, Validations, and Risk Management tasks via the Change Control Management Site System.

+ Contribute to the Quality Supplier Management activities

+ Review, update and contribute to the development of site procedures.

+ Ensure Quality Agreements with clients are established and maintained.

+ Contribute to the site’s improvement on site projects.

Keys to Success:

Education

+ BS degree required, or M.Sc. in Pharmacy, Chemistry, Science or a related field preferred.

Experience

+ At least 2 years of experience working with Quality Management Systems.

+ Experience in working in project teams high preferred.

Knowledge, skills, abilities

+ Knowledge of directives (EU-GMP, US FDA 21 CFR).

+ Structured and very diligent working style including ability to organize yourself independently.

+ Analytical skills with proven ability to troubleshoot complex problems.

+ Strong interpersonal skills to work as a member of a team and collaborate effectively with other Teams and Functions.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.