Quality Consulting Group, LLC

JT373 - ASSOCIATE MANUFACTURING

Quality Consulting Group, LLC  •  Holly Springs, NC (Onsite)  •  19 days ago
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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:

  • Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR] with strict adherence to safety and compliance.
  • Ensure proper gowning and aseptic techniques are always followed
  • Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and assigned area
  • Buffer and Media preparation and transfer
  • Weigh and dispense of materials to be used in the preparation of Buffers and Medias
  • Complete washroom activities: cleaning equipment, small to large scale, use in production activities
  • Run and monitor critical process per assigned procedures
  • Perform documentation for assigned function (i.e., equipment logs, EBRs)
  • Maintain an organized, clean, and workable space


Qualifications:

  • High school diploma / GED + 1 year of manufacturing and/or other regulated experience
  • Completion of NC BioWorks Certificate Program
  • Experience in a regulated industry such as biotechnology or pharmaceutical
  • Basic understanding of GMP principles
  • Strong verbal and written communication skills
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
  • Ability to perform assignments with a high degree of focus/attention to detail.
  • The initial schedule will be Monday-Thursday or Tuesday -Friday, 10 hours days.
  • The schedule will transition to shifts (rotating 2-2-3, 12 hour shifts) upon completion of startup activities and as business needs dictate.

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.

Quality Consulting Group, LLC

About Quality Consulting Group, LLC

The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.

Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matters.

Industry
Consulting & Advisory
Company Size
11-50 employees
Headquarters
San Juan, PR
Year Founded
2011
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