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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:

+ Responsible for loading materials into machines.

+ Schedule manufacturing operations.

+ Perform initial review of manufacturing procedures and batch records.

+ Train Manufacturing Operators and Associate Manufacturing staff on process theory.

+ Draft and revise complex documents (e.g., Manufacturing Procedures, SOPs, technical reports, validation documents, investigation reports).

+ Audit critical manufacturing records.

+ Propose corrective actions for quality incidents.

+ Assist in and plan improvement implementations related to routine functions.

+ Collaborate with other departments to implement planned improvements.

+ Identify and propose solutions to complex problems.

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

+ Lead equipment and process operations.

+ May assist with recruiting efforts.

+ May supervise staff.

+ May perform system owner responsibilities (e.g., for process or documentation).

+ May collaborate with Process Development.

+ When assigned to assist the Process Owner under supervision of a Manufacturing.

+ Support the generation and review of manufacturing procedures and related documentation.

+ Troubleshoot processes and assess performance through process monitoring.

+ Participate in the NC/CAPA process by performing process assessments, contributing to investigations, defining/implementing CAPAs, and reporting on incident trends.

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

+ Support new product introductions and product lifecycle activities.

+ Initiate and implement Level 1 and Level 2 Change Control records.

Qualifications:

+ High school/GED and 1 year of work or military experience OR Associate degree

+ GMP experience is preferred but not required.

+ Basic computer proficiency is preferred but not required.

+ Mechanical aptitude and technical expertise.

+ Understanding of equipment and manufacturing processes.

+ Good knowledge of GMP and the ability to apply regulatory expectations.

+ Ability to stand for long periods and lift up to 35 lbs.

+ Strong possibility of conversion to full-time for the right candidate.

+ Available to work overtime.

+ Working shift: 2nd shift (Monday–Friday, 2:30pm to 11:00pm) for the first four months.

+ Will transition to evening shift (Mon–Thurs, 3:30pm to 2:00am)

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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