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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:

+ Performs manufacturing processes according to Standard Operating Procedures.

+ Must be proficient at Associate Manufacturing and may perform those functions in addition.

+ Perform initial review of manufacturing procedures/batch records.

+ Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)

+ Audit critical records.

+ Propose corrective action for Quality incidents.

+ Assist & plan improvement implementation related to routine functions.

+ Interact with other departments to implement planned improvements.

+ Identify and propose solutions to complex problems.

+ Perform data analysis (e.g., SPC, CPV) of critical process parameters.

+ Lead capacity for equipment/process operations.

+ May perform system owner responsibilities (i.e., process, document).

+ Supports manufacturing procedures (and other related documentation) generation and review process.

+ Troubleshoots process and assesses process performance thru process monitoring.

+ Supports NC CAPA process by completing process assessments and participating in cross functional investigational teams, defining and implementing CAPAs and reporting incident trending.

+ Assists in the generation, review and execution of process validation protocols.

+ Supports new product introduction and product life cycle.

+ Initiates and Implement Level 1 and Level 2 Change Control records.

Qualifications:

+ Bachelor’s degree in Life Science and/or Engineering

+ 1-3 year of experience in manufacturing preferably in a FDA regulated environment.

+ Mechanical ability/expertise.

+ Understand equipment/processes.

+ Technical writing capability.

+ Ability to interpret and apply GMP concepts.

+ Understand analytical methods for manufacturing area.

+ Basic project management skills.

+ Shift: 3rd shift from 3:30pm - 2:00 AM (Mon – Thu)

+ Some Fridays are worked and overtime.

+ Can expect to need to work OT 2x/month on average

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.

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