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Form of workQUALITY 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 manual visual inspection and testing in manufacturing operations team.
- Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures
- Operate critical processing equipment.
- Process improvement projects/assignments within operations.
- Use of Quality systems (LIMS/MES/SAP/MAXIMO) execution
- Support new product introduction activities.
- Supporting manufacturing production operations
- GMP documentation
- Interfacing with computerized systems
Qualifications:
- Associate Degree in related area
- 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- Experience with manual visual inspection and/or laboratory 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 and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
- Ability to understand analytical methods for manufacturing/laboratory area
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position.
- Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
- Able to perform initial review of manufacturing/laboratory procedures/batch records
- Day shift is 7am-4pm. Some training does require a start time of 6am.
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.
