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:
- Picking, reviewing, shipping, dispensing, and other tasks in support of Distribution/Dispensing.
- Consistently follow Standard Operating Procedures (SOP's) and departmental policies with strict adherence to current Good Manufacturing Practices (cGMP's).
- Material handling associated with the movement of materials within a warehouse setting.
- Gown to grade 8-9 and work in a classified Dispensary.
- Material handling/dispensing and all associated cleanings. Staging materials for transport and delivery.
- Support and identify escalating potential risks associated with shipping/dispensing activities.
- Collaborates with cross-functional teams in completing operational activities associated with shipping/dispensing.
- Supports Continuous Improvement initiatives, programs, and projects.
- Actively participate in Work Center Team efforts as well as Safety programs.
- Provides support during regulatory inspections and be ready to present information to auditors (as required).
- Support ATO external warehouse operation teams and all associated tasks.
- Collaborate with Global Distribution Teams to meet ever evolving needs of the business.
- Complete all transactions in a prompt and correct/compliant manner.
Qualifications:
- Bachelor's degree or Associate's degree and 4 years of experience.
- Polished GMP professional with Shipping, Dispensing, Warehousing, Manufacturing and/or Quality experience.
- Support documentation revisions in CDOCS.
- DQMS (Digital Quality Management System) and QMTS (Quality Management Tracking System) knowledge, supporting deviation investigations including initiating and owning minor deviations and CAPAs.
- Must be available to work various shifts as needed (day, swing, weekends, holidays) as dictated by the production schedule.
What We Do
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 matter
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