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:        

• Performs manufacturing processes according to Standard Operating Procedures. 
• 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 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 Specialist or Senior Manufacturing Specialist:
• 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 experience
• Mechanical aptitude and technical expertise
• Understanding of equipment and manufacturing processes
• Proficiency in statistical and mathematical analysis
• Good knowledge of GMP and the ability to apply regulatory expectations
• Understanding of analytical methods relevant to the manufacturing environment
• Familiarity with specific manufacturing systems or equipment
• Basic project management capabilities
• Prior experience in GMP environments or basic computer proficiency is preferred 
• Must be proficient in Associate Manufacturing functions and may perform those duties as well.
• PPE is provided onsite, and candidates must be comfortable working in a fast-paced, physically active environment.
• Day shift (Monday–Friday, 9:00 AM to 5:30 PM) and is expected to transition to a second shift schedule after approximately four months, with shift differential applied.
• After 4 months able to transition to evening shift (Mon–Thurs, 3:00 PM – 1:30 AM or 3:00 PM – 11:30 PM depending on business need)
• CANDIDATES MUST BE WILLING TO TRANSFER TO THE SECOND OR NIGHT 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.

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