Job Description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Support product transfer activities, mainly focus on process validation and release product up to commercial release.
• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.

Qualifications:

• Bachelor’s degree in related area
• 3+ years of relevant experience
• Experience with process failure mode analysis and first time quality.
• Knowledge on Sterilization
• Knowledge in Final Pack
• Process Validation, Statistical Analysis, Process Failure Mode and First Time Quality
• 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.