We are looking for cold supply chain quality engineer person who has 4+ years of experience with technical science and/or engineering and experience with pharmaceutical qualification/validation processes, preferably with shipping, equipment and/or facility qualification/validation.
Responsibilities: • Provide interpretation, guidance, and training for clients regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization. Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision. • Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.). • Support CAPA activities related to validation and qualification. Provide guidance, direction, and support to peers.
Experience: • 4+ years of experience with technical science and/or engineering education. • Technical science and/or engineering education • Experience in life sciences industry, preferably in pharmaceutical GMP and/or GDP regulated environment • Experience with pharmaceutical qualification/validation processes, preferably with shipping, equipment and/or facility qualification/validation • Experience writing technical reports and quality system procedures • Experience writing, coordinating and executing qualification/validation activities (including validation plans, protocols, summary reports)
Education: • 4-year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology. • Minimum of 4-7 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance. • Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.). • Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, Qualification and Validation. Excellent communication capabilities and teamwork capacities. • Proven ability to work in a global environment and on virtual teams.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.