Sr. Quality Specialist

Location: Summit, NJ or New Brunswick, NJ

Duration: 06 Months

Pay Rate: $55 to $58.53/hr. on W2

50% onsite- across two week period, mandatory 2 days in office per week, 3rd day every other week.

Work Schedule: Mon
-Fri (normal business hours)

This position provides quality oversight for material suppliers and vendors used to manufacture, package and test client clinical and commercial products in accordance with client policies, standards, procedures and international cGMPs. The incumbent will be responsible for the approval activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, packaging and testing of client products.

To the latter, the incumbent will also have additional responsibilities that include but are not limited to, providing quality support to client stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring supplier quality system documents.

• The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
• Quality oversight of the activities and services provided by suppliers:
• Serves as the site single point of QA contact for client Direct and Indirect material suppliers.
• Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.
• Initiate and Manage Supplier Quality risk assessments.
• Create / negotiate and maintain Supplier Quality Agreements.
• Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs; ensures properly documented per client procedures.
• Support the conduct of investigations into supplier-related issues, including quality incidents, non-conformances, and supply chain disruptions.
• Serve as lead investigator for global (multi-site use), Class 3 or below suppliers.
• Perform quality approval role for supplier investigations.
• Collaborate with cross-functional teams, such as Quality Assurance, Supply Chain, Material Science, Procurement and Regulatory Affairs, to gather relevant information and data for the investigation.
• Utilize investigative techniques, such as root cause analysis, to identify the underlying causes of supplier-related issues.
• Evaluate and communicate supplier quality related changes, ensuring assessment per client change control procedures and documented in a timely fashion.
• Collect APR-PQR related information and data per client requirements.
• Support client audits at suppliers with pre-audit preparation information and post audit CAPA follow up, as needed.
• Coordinate / Support the Supplier Quality Review Board to promote discussions surrounding Supplier Quality Vendor Changes and Supplier Issues, as well as the approval process for new suppliers.
• Measure supplier quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with supplier to define possible areas for improvement and associated implementation plan.
• Collect supplier quality documentation necessary to support regulatory submissions.
• Hold or support appropriate periodic quality meetings with supplier representatives, as needed.
• Hold or actively participate in joint periodic meetings with stakeholders.
• Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system
  -e.g. support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner.
• Partner with stakeholders to assess overall supplier performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk-based approach.
• Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
• Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate.
• Author necessary quality system documents; review and update procedures for client Quality Management System per process ownerships.
• Support…