Thermo Fisher Scientific QC Scientist III - Compendial Changes 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.
How will you make an impact?
Acts as SME for all regulatory requirements an expectations for managing Provides complex analyses in a chemistry or microbiological environment by selecting appropriate methods with independent judgement. Performs analytical methods for complex testing on raw materials, samples, stability, environmental, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or and antimicrobial effectiveness tests. Supports internal development and/or manufacturing operations. Makes detailed observations and analyzes, resolves issues, documents, and communicates test results.
What will you do?
Acts as point of contact and owner of all of compendial process including interactions with global (e.g., USP and EP) and national pharmacopeia.
Acts as subject matter expert in regulatory requirements and expectations for managing compendial changes (product monographs as well as general chapters).
Conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
Leads the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional wet chemical testing. Determines which methods will be used.
Evaluate global documents against site specific procedures and update the site procedure accordingly.
Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies , SOPs, compendial, ICH, DEA and FDA regulatory guidance.
Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
Generates change requests required for analytical documents, and routes documents for review and approval.
Coduct Lab Event/Out-of-Specification and Out-of-Trend investigations and closed on timely.
Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across site and functions.
Collaborates with colleagues and external partners to achieve individual and department goals.
Verifies and processes analytical data for method transfer.
Facilitates development of quality products through participation and representation on group and department level project teams.
Makes determination to resolve out-of-specification or unexpected results and analytical and product problems.
Develops documentation processes. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Interacts with clients directly.
Leads, prepares, and files regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
Coordinates and leads writing of SOPs, policy manuals, and other instructional documents.
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
How will you get here?
Bachelor's degree in Chemistry
Chemistry License, preferred
Five (5) years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. In-depth knowledge of compendial processes including interactions with global (e.g., USP and EP) and national pharmacopeia.
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
Expert knowledge and understanding of chemistry and analytical instrumental technologies.
Expert knowledge of qualitative and quantitative chemical analysis.
Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
Advanced in problem solving skills and logical approach to solving scientific problems.
Excellent proficiency skills with HPLC, GC, LC/MS and dissolution techniques (method development and validation).
Working knowledge of analytical techniques used in commercial testing of raw materials, excipients, and drug substance and drug products required, preferably with pharmaceutical products.
Excellent facilitation and project management skills, with strong verbal and written communication skills.
Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives; and lead by example
Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
Capable of working and communicating effectively with all levels of the organization Spanish and English .
Computer literate (Microsoft Office, SAP, Trackwise, among others)
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.