At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Pharmaceutical Services Group – Oral Solid Dosage

How will you make an impact?

Quality Leader work as partner with internal and external clients to drive excellence... in our processes. As part of our organization will have the opportunity to deliver products with high quality standard. Our mission is to support, improve and maintain Quality Systems compliance to meet client expectations by providing excellence in service. Reinforce quality systems to assure that production processes, at all stages, are in compliance with established procedures (SOP’s), specifications and cGMP’S. Assure that all GxP related to any given Client are according to specific clients Quality Agreement.

What will you do?
• Accountable of the approval & oversight of manufacturing and quality activities associated with exceptions, CAPA, deviations, process validation, equipment qualification, change control requests, and other documentation related to Mfg, QC and QA operations.
• Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate & approve these quality system elements, as delegated by management.
• Interact with the clients for all related quality aspects of the product manufactured
• Measures and reports on key performance indicators at the site and customer level.
• Assure effective corrective action plans in conjunction with manager to address any areas of concern are in placed.
• Evaluate process and conduct risk assessment to diagnostic trends, major offenders, among others indicators, applying lean manufacturing, six sigma and/or root cause analysis tools to provides recommendations and improve processes and activities.
• Assure all quality systems following corporate policies, standard operating procedures (SOP’s) and product specifications.
• Assures Quality SOP’s are current and align with corporate policies, standard, and/or practices.
• Provides mentoring and training to QA personnel.
• Supports continuous improvement philosophy by identifying and recommending corrective and preventive actions on findings and/or tendencies plant wide, including clients.
• Attends multidisciplinary operations meetings to share and communicate quality measurement information and provide support service as required.
• Establishes measurement systems through use of statistical process control tools and efficiency indicators such as “right the first time”, cycle time, among others.

How will you get here?

Education

Bachelor’s degree in Science, Engineering or related field required; Industrial Engineering preferable.

Experience

At least 3-5 years of experience in a multidimensional role within subcontract manufacturing, pharmaceutical or medical device environment; plus shown experience on quality related functions.

Equivalency: Equivalent combinations of education, training, and meaningful 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).
• Works on issues of moderate to high complexity in regards to processes and product within quality & regulatory compliance and data integrity.
• Knowledge in Process improvement tools and implementation (Six Sigma, Lean Manufacturing, Risk Assessment, Root Cause analysis)
• Experience with quality protocols, quality investigations and CAPA.
• Experience handling quality compliance documentation and technical writing skills.
• Analytical and Quality approach.
• Ability to work in a fast paced environment, able to multi-task and results driven.
• Self-directed, persistent, goal-oriented, independent and diligent.
• Effective time management and prioritization skills.
• Shown excellence in customer service skills.
• Interpersonal effectiveness and rapport building to establish and maintain working relationships with internal and external customers.
• Highly effective communication verbal and written in Spanish & English.
• Proficiency presentation skills to present information to high level management, customers, and employees.
• Computer proficiency/software skills (i.e. Outlook, Excel, Word, PowerPoint, Trackwise, SAP).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued
Puerto Rico

Salary Criteria