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:

• Manufacturing support role responsible for manual visual inspection.
• Work in a dynamic production environment at site supporting development, clinical, and launch activities.
• Under general supervision, employee will perform operations in the Manufacturing area.
• Operations will be performed according to Standard Operating Procedures (SOPs).
• Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
• Performing and monitoring critical processes with the ability to perform basic troubleshooting
• Working in a GMP room environment, full clean room gowning, hairnet and gloves when performing all work.
• May require entry into classified areas that require donning of coverall attire.
• Drafting and revising documents (SOPs, MPs)
• Identifying, recommending, and implementing improvements related to routine functions
• Assisting in the review of documentation for assigned functions (equipment logs, batch records).

Qualifications:

• Bachelor’s degree in related area
• 1 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
• Requires a passing eye exam for color.
• 4 years of Manufacturing /Operations experience 
• Experience with manual visual inspection or in a GMP regulated environment.
• Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
• Knowledgeable of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
• Demonstrated ability to work in a team and professional environment.
• Experience in manufacturing execution systems
• Shift 7am-4pm. Some training does require a start time of 6am.
• Possibility to move to graves/swing shift but job seekers should be flexible. 

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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