Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
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:
Join Thermo Fisher Scientific Inc. as a QA Manager in Manatí. This is an outstanding opportunity to lead and manage our Quality Assurance Department focus on Quality Systems. Our focus is on flawless execution, ensuring that our quality systems and product releases meet the highest standards. This role is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and global regulatory requirements.
A Day in the Life:
- Evaluate and integrate quality processes related to Pharmaceutical Services and Commercial Operations.
- Manage the Change Control program, Deviations, Controlled Substances Program, Vendors Program, Complaints, SOPs, and Annual Product Review.
- Ensure compliance with cGMPs, company policies, procedures, and other applicable regulations.
- Provide technical support and direction for multiple issues, ensuring timely resolution.
- Conduct daily review of documents and investigations to ensure timely product releases.
- Maintain quality systems metrics and manage departmental budgets.
- Interact with clients to resolve quality issues related to their products.
- Participate as an escort during regulatory audits (FDA, DEA, MCA, Client, or Internal).
- Examine and record all complaints and deviations strictly within required timelines.
- Support Controlled Substances regulations, licenses, and inventories, managing DEA audits and communications.
Keys to Success:
Education and Experience
- B.Sc. in Chemistry, Pharmacy, Microbiology, or Engineering required.
- 7+ years of QA/QC experience in the pharmaceutical industry with 2+ years’ experience in a Supervision role.
- Proven capability to perform management duties.
- Knowledge of cGMP and FDA compliance.
- Strong interpersonal and communication skills, leadership ability, and organizational skills.
- Proficiency in English and Microsoft applications.
- Formal approval of qualifications by site and/or corporate QA against local regulatory requirements for GMP compliance.
- Experience in pharmaceutical or oral dosage products preferred.
This position does not offer relocation benefits.
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!
