Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Preferred Qualifications:

• Knowledge in CSV full cycle
• Knowledge in Process Validation Full Cycle, FAT, SAT, IQ, TMV, CSV, PCR, OQ and PQ
• Knowledge in GAMP principles, basic software change knowledge, Validation Statistics Knowledge

Education & Experience:

• Bachelor of Science in Engineering with 5 or more years of directly related experience

Job Types: Full-time, Contract

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Juncos, PR 00777: Relocate before starting work (Required)

Work Location: In person