Work Schedule

First Shift (Days)

Environmental Conditions

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

Job Description

Title: Quality Specialist III (Pharmacist)

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 at our Manati, Puerto Rico, site and will report to our Site Quality Head. The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

Discover Impactful Work:

Join our team as a Quality Specialist III (Pharmacist) at Thermo Fisher Scientific Inc., where your expertise will contribute to our world-class standards! This is an outstanding opportunity to work with a dynamic team dedicated to making a significant impact. Serve as the controlled substance SME for the Site CS Program. Implement, maintain, and ensure ongoing compliance of the site CSP with Group Level policies.

A Day in the LifeBuild and maintain the site’s Authorize User list.

Ensure registration, procurement, storage, inventory, handling, security, and distribution of CSPPs align with all relevant regulations and detailed site requirements.

Conduct controlled substance awareness training for associates and leadership at their respective levels.

Collaborate with DEA inspectors and manage inspections.

Manage Site CS Inventories and ARCOS reports.

Ensure accurate management and support during the CS waste destruction process.

Coordinate the site licensing renewal process and ensure compliance with TTB (SDA Alcohol) regulations and site inventories.

Challenge, assess, and assist the QA department on quality issues as required.

Interact with clients' QA on any quality issues regarding approval and follow-up actions to DRs.

Assist Quality Systems in client audits when needed.

Keys to Success: Education

B.Sc. in Chemistry, Pharmacy, Microbiology, or Engineering is required.

Valid Pharmacy license is highly preferred.

Experience

Minimum 3-5 years' experience in the pharmaceutical industry.

Experience in managing controlled substances and compliance programs required.

Experience with quality systems and audits required.

Knowledge, Skills, Abilities

Strong knowledge of DEA regulations and guidelines.

Outstanding organizational and communication skills.

Ability to successfully implement and maintain compliance-related processes.

Excellent interpersonal oral and written communication skills. 

Proficiency with the English language.

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.