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 and packaging of post-inspected units.
• Manual visual inspection
• Interface with GMP systems
• Under minimal supervision, performs manufacturing according to Standard Operating Procedure
• Operate critical processing equipment
• Assist in ensuring operations are completed per manufacturing schedule
• Responsible for identifying and communicating problems during operations
• Review, revise, and audit documents.
• Perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)

Qualifications:

• Associate degree preferred
• 1-year minimum GMP background manufacturing, computer savvy, SAP Knowledge is helpful as candidate will need to use Manufacturing Execution System.
• Experience with manual visual inspection of drug product 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)
• Require a passing eye exam, which includes color.
• The current shift structure is 6am-3pm.
• Some training does require an earlier start time of 4am/5am.
• Some processes may require earlier shift start times and/or weekend work to meet production demand.
• 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.