QC Incoming Inspector I

Company Name: Anika

Summary of Primary Responsibilities:

The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing.

Specific Responsibilities:

• Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements
• Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications
• Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory
• Review MPS of other incoming inspectors for approval and release.
• Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation
• Perform OOS investigations and participate in MRB as required for rejected materials
• Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel
• Perform biennial review for designated procedures and MPS as needed
• Documents; author and complete DCR as required
• Document all work activities according to Good Documentation Practices
• Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
• Participate in other projects as assigned

Job Complexity:

The position works on assignments that are routine in nature and receives detailed instruction on all work.

Supervisory Responsibilities:

None

Required Qualifications:

• Associates degree in the life science or relevant work experience
• 0 – 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered
• Experience using Microsoft Office or an ERP system

Desired Experience, Knowledge, and Skills:

• Bachelor’s degree preferred
• Experience working in a clean room environment
• Excellent communication and documentation skills