Product Quality Complaints Sample Room Technician

ET_TN01
Title: Product Quality Complaints Sample Room Technician
Locations: Framingham, MA-onsite, 5 days a week
Duration: 12 Months
Pay Rate: $25.00/h- $30.00/hr on W2 All Inclusive
Work Schedule: 9:00 AM - 5:00 PM EST- Hours are somewhat flexible if they want to start earlier to end a little earlier

Day in the life:

1. Operating product quality complaints.
2. Responsible for end to end processing (receiving sample, processing, prep for shipment)
3. need to wear PPE, make call backs to get more info, main role is to prep samples for shipment, working with FedEx shipping.
4. Not a desk position, not scientific/lab work, but is in a clinical setting.
5. The PPE is because they are handling samples. There will be lots of moving, working with one other team member.
6. Lift up to 20lbs, 50% of work is standing, 50% entering data.

Job Description:

1. Manage E2E sample returns process related to product technical complaints for medical devices, pharmaceutical products, biologics and combination products per internal procedures and regulatory requirements.
2. Manage supplies and maintain inventory, equipment and tools required for sample room operations . Act as a subject matter expert on sample returns process during audits and inspections.
3. Years of Experience: 2 years of pharmaceutical industry experience

JOB SUMMARY
This position is responsible for activities related to management of Product Technical Complaints for medical devices, pharmaceutical products, biologics and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance and complaint handling is preferred.

II. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
PQC Sample Room
• Responsible for E2E operations conducted in PQC Sample Room
• On site support 5 days/week, ability to work wearing PPE
• Responsible for handling used complaint samples
• Process returned complaint samples as per PQC Sample Room Manual
• Identifies and handles lot discrepancies correctly with returned complaint samples.
• Updates the complaint records in the systems.
• Prepares products for shipments to the manufacturing sites
• Prepare shipping labels using FedEx equipment.
• Assemble shipping containers to the sites.
• Deliver assembled mailers to main Client mail room or arrange for daily pick up
• Responsible for resolving all discrepancies directly with the reporters
• Create new complaints in both Meteor and Qualipso
• Identify complaints for FAR/BPDR (Field Alert and Biological Product Deviation Report) reporting as necessary
• Use various Excel reports for daily operations.
• Act as a SME on PQC Sample Room operations and provide support during audits and inspections
• Act as a trainer for new associates
• Manage PQC Sample Room Manual
• Complete all required trainings (i.e. DOT, IATA, blood borne pathogens)
• Manage all supplies and maintain inventory required for daily operation of a PQC Sample Room