RTP IQA Supervisor

Position Title:

Supervisor – QA Incoming

Job Level:

B5

Job Family Group/Family

Quality – Quality Assurance

Supervisor:

Associate Director – Materials QA

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.