Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

QA Compliance 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.

Discover Impactful Work:

Responsible to maintain the Quality Systems in compliance with Current Good Manufacturing Practices (cGMPs), Global Regulatory requirements, company policies, procedures and all other applicable regulations and guidelines. Tasks under Quality Compliance / Quality Systems responsibilities such as, to lead Internal / External Audits (Clients Audits and Regulatory Inspections), client’s none routine requests aligned to regulatory requirements for the site operation among others. Also, management of Change Control system, preparation of Annual Product Report (APRs), Quality Agreements, Deviations/Observations review and or approval. Management of Vendor Program, Customers Complaints and Global documents evaluation.

A Day in the Life:

​ Documentation / Client Focus (90%)

• Review and approve protocols and reports

• Review, approval and propose revisions to (SOPs) Operational procedures.

• Prepare client request and certifications

• Hosting Regulatory Agency and client’s audits, reports and CAPA follow up

• Support to other Quality Systems programs

Task – Safety & Compliance (5%)

• Environmental Health and Safety – identify and take actions to prevent unsafe conditions.

General (5%)

• Support site initiatives and preparation of Metrics

Keys to Success:

Education and Experience

• B.Sc. in Chemistry, Biology, Life Sciences or another related field required.

• 3+ years of experience in a quality role in the pharmaceutical or similar industry.

• Excellent interpersonal oral and written communication skills.

• Proficiency with the English language.

• Experience with Microsoft Word and Excel and Teams. Knowledgeable of electronic systems such as: Global TrackWise®, eDMS, Success Factor.

WORKING CONDITIONS:

Physical Effort:

There is little physical effort and fatigue. Walks, stands, lift small objects and tools or operates keyboard equipment, and medium physical effort activity such traveling/driving.

Physical Environment:

Located in a comfortable indoor area. Any unpleasant conditions would be based on the audit to be site for a short duration.

Sensory Attention:

Regular need to attend closely to sophisticated or subtle stimulus that requires phenomenal diligence and attention for accurate interpretation.

Mental Stress:

There is regular pressure from deadlines, accuracy, or similar demands.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, 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. We will gladly provide reasonable accommodations covered under the ADA.

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.