Quality Assurance Specialist IV, Quality Operations (Remote)

Gaithersburg, MD

Posted: 09/14/2023 Industry: Scientific Job Number: 23-00446

Job Description

Quality Assurance Specialist IV, Quality Operations
Must be comfortable with meetings in EU.
6- 7 am EST start time preferred.

We are seeking a Distribution Quality Specialist IV to join our Quality Ops Materials This position is responsible for routine Quality oversight of Supply Chain and Distribution and associated materials management activities. The position is responsible for ensuring the warehouse and area personnel activities remain in compliance with CFR, FDA and ICH Guidances, global regulatory expectations, and international cGMPs. Responsibilities include providing quality oversight for area specific change controls, deviations and CAPAs and participating in and reviewing investigations. The position will provide quality oversight for Materials Management including transportation, receiving, materials storage and materials management operations at the
internal and external manufacturing warehouse.

This position reports directly to the Quality Assurance Director.
Responsibilities include but are not limited to:
Create and/or approve SOPs, temperature deviation investigations, and change controls as part of GMP quality compliance. Contribute to contract reviews such
as Quality or Supply Agreements
Quality oversight for domestic and international shipments through delivery, including transactions for reconciliation in SAP.
Ensure shipping and handling and storage are in line with quality requirements.
Provide oversight for Materials Management, and Supply Chain activities such that they always remain GMP compliant.
Provide Quality oversight of day-to-day shipping, receiving, materials storage and issuance, and other Materials Management and Supply Chain activities.
Provide guidance and support in responding to deviations associated with warehouse and materials management operations. Confirm thorough and
effective CAPAs are implemented as necessary.
Ensure that change controls for the area adhere to requirements and provide area impact assessments for change controls.
Responsible for quality oversight of shipping requirements, temperature excursions
Communicate with Distribution/Supply Chain management for Quality related issues.
Notify Quality Management of any quality issue that may be regulatory significant or impact the acceptability of product or materials.
Contribute to weekly distribution team meetings.
Write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications
Support Quality Operations as required including review of deviations and support of CAPAs and Change Controls as it pertains to manufacturing and
materials management operations.

Minimum Requirements:
Bachelor's degree in biology, Chemistry, Engineering, BS with 5+ years'
experience in the Pharmaceutical/Biotech industry
Strong knowledge foundation of FDA and EU regulations regarding the
manufacturing of biologics (210, 211, and 610 CFR and Eudralex Vol 4)
Understanding of Quality Assurance systems
Strong communication and organizational skills
Preferred Requirements:
Demonstrated ability to manage multiple priorities and maintain adherence to
Demonstrated ability to manage process improvement projects
Demonstrated ability to identify and implement cross-functional improvements
Demonstrated ability to maintain relationships across the organization
Demonstrated knowledge of quality systems
Demonstrated ability to lead complex investigations with minimal supervision

Meet Your Recruiter

Clarence Alphonso

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