Incoming Quality Assurance Supervisor

4 weeks ago

Durham, United States Medasource Full time

Position Title:

Supervisor – QA Incoming

Job Level:

B5

Job Family Group/Family

Quality – Quality Assurance

Location:

Research Triangle Park

Position Description:

Our client has a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The QA Leader –Incoming Inspection is responsible for providing leadership to the Quality – Incoming Inspection team. The QA Leader – Incoming will oversee the incoming materials, including goods receipt, sampling, incoming inspections/testing, and inbound/outbound shipping processes.

Key Objectives/Deliverables:

  • Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
  • Manage the QA – Incoming team, consisting of 4-6 Quality Specialists.
  • Responsible for training and managing the QA – Incoming team in:

o Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.

o Documenting inspections in accordance with procedures and specifications.

o Ensuring materials not meeting specifications are quarantined, per local procedures.

o Sampling, inspecting, and documenting results utilizing electronic systems (Darwin, SmartLab, etc).

o When sampling a portion of the batch, ensure proper sampling plan is followed.

o Working with the QC Lab to deliver samples and receive results

o Performing ID testing of materials utilizing Raman or NIR Spectroscopy.

o Maintaining retains and samples per local procedures.

o Communicate with QA Disposition team to ensure materials are released in a timely manner, as to not delay production.

o Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.

o Ensuring storage condition is tracked, accurate, adjusted (as needed) including evaluating temperature excursions on shipments received at the warehouse.

o Assists in resolving issues on inbound shipments (i.e.incorrect quantity or product, contamination, etc.).

o Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)

o Provides additional Quality support to warehouse, as necessary.

  • May need to assist with performing department activities to ensure materials are available for production.
  • Responsible for ensuring team is trained and training remains in compliance.
  • Communicates with Associate Director and Quality Representatives on quality issues.
  • Lead, mentor, and coach QA – Incoming team, Operations, and support personnel on quality matters, while supporting and driving the site Quality culture.
  • Ensure regular presence in operational areas to monitor GMP programs and quality systems.
  • Work with materials management group to initiate complaints/remarks to supplier for materials not meeting Client expectations.
  • May participate in investigations regarding materials or service complaints.
  • Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule.
  • Authors/revises SOPs, materials specifications, as needed.
  • Interacts with other quality functions including QA Warehouse
  • Supports material related Supplier Change Notification's (SCN).
  • Participates in/supports regulatory inspections, as needed.


Requirements (Education, Experience, Training):

  • High school diploma


Preferred attributes but not required:

  • Previous materials or warehouse experience.
  • Previous experience leading and managing a team.
  • Demonstrated understanding of cGMP regulations related to QA Inspection applications.
  • Strong attention to detail.
  • Proficient in computer system applications.
  • Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.
  • Excellent interpersonal and networking skills.
  • Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.
  • Understanding of statistical tools and analysis.
  • Experience in inventory management systems (SAP, etc.)
  • Previous experience in GMP production environments.
  • Previous facility or area start up experience.

Other Information:

  • The position is for the Client Research Triangle Park site and will support a 24/7 operation
  • Ability to support off-shift requests
  • Ability to work 8 hour days – Monday through Friday.
  • Ability to work overtime as required.

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