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
- Focused on manual visual inspection.
- Opportunities to expand training to analytical testing.
- Manufacturing support role responsible for manual visual inspection.
- Under minimal supervision, performs manufacturing according to Standard Operating Procedure
- Operate critical processing equipment
- Assist in ensuring operations are completed per manufacturing schedule
- Resource related to processing operations on the mfg. floor
- Responsible for identifying and communicating problems during operations
- Review, revise, and audit documents
- Perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
- Manual visual inspection
- GMP documentation
- Interface with MES / SAP
Qualifications
Associates degree in related area1-year minimum GMP background manufacturing, computer savvy, SAP KnowledgeExperience with manual visual inspection of drug product, analytical testing lab, or in a GMP regulated environment.Experience with PAS X Werum software for electronic batch records with some understanding of editing and validationKnowledgeable of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)GMP experience in biotech manufacturingAttention to detail (visual acuity), must pass eye exam for color, depth, and 20 / 20Experience with GMP documentationDemonstrated ability to work in a team and professional environment.Shift is 6am-3pm.Some training does require a start time of 5am.Possibility to move to graves / swing 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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