Thermo Fisher Scientific QA Manager in Manati, Puerto Rico
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Pharmaceutical Services Group
How will you make an impact?
Manage the Quality Assurance activities within the Site to assure that all operations related to the manufacturing of the pharmaceutical products are performed in accordance with the current Manufacturing Practices (cGMP's), with the Food and Drug Administration (FDA) regulations and with the standards for product quality of Patheon, part of Thermofisher.
What will you do?
Provide tracking and trending of quality statistics, including first time quality. Use data analysis and investigations to determine root cause for issues and provide leadership and guidance within the organization for quality improvement initiatives.
Oversee the consistency of and implementation and completion of validation requirements within the plant operations and quality areas per regulatory requirements.
Assure appropriate CAPA systems are in place and followed.
Responsible for assuring that Investigation, Complaints, Product Annual review and SOP's Programs Systems are in place.
Manage Client quality assurance liaisons for potential customers as well as for existing Clients and their products.
Manage plant wide documentation systems to assure easy paperwork generation, archival and retrieval mechanisms in compliance with cGMP requirements.
Assist in the development and management of quality assurance budget process and execution within define guidelines.
Support QA Compliance meetings to discuss open investigations to focus them to the right judgment and pending corrective/preventive actions to assure completion on time.
Assure QA investigations are closed within thirty (30) calendar days and corrective/preventive actions are executed on time. If this is not possible, she/he is responsible to request and justify an extension for the completion.
Revise and approve documents like Validation Protocols, Change Control Form, Specifications, Methods, Batch Records, Standard Operating Procedures, etc.
Provide tracking and trending of quality statistics, including first time quality. Use data analysis and investigations to determine root cause for issues and provide leadership and guidance within the organization for quality improvement initiatives
How will you get here?
Bachelor's degree in Science or related field is required, Chemist preferable.
Five (5) to Ten (10) years' experience in quality functions with increasing responsibilities in Quality Assurance, preferably on a subcontract manufacturing environment.
Equivalency : Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
Strong understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and current Good Documentation Practices (cGDP).
Proven management capabilities
Works on issues of moderate to high complexity in regards to compliance of processes and product within quality & regulatory compliance and data integrity.
Ability to work in a fast paced environment, able to multi-task and results-oriented.
Self-starter, mature, independent and dependable.
Effective time management and prioritization skills.
Excellent interpersonal skills to establish and maintain effective working relationships with internal and external customers.
Highly effective communication verbal and written in Spanish & English, must.
Expert presentation skills to present information to high level management, customers, and employees
See above computer proficiency/software skills (i.e. Outlook, Excel, Word, PowerPoint, Empower, LIMS, Trackwise).
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.