Senior QC - Incoming Materials Inspector

Anika Therapeutics; Bedford (MA); On-site; USD 39,000 - 48,000; Full time

Job summary

Anika Therapeutics, based in Bedford, MA, is seeking a Senior QC Incoming Inspector to lead material inspection and release activities for raw materials and components used in manufacturing. You will provide SME guidance, review documentation, and ensure GDP-compliant records with strong attention to detail.

The role requires at least 4 years in a cGMP-regulated environment, experience with MPS/DHRs, and proficiency in Microsoft Office and ERP systems.

Qualifications

• High school diploma or equivalent required; additional technical or scientific education is preferred.
• Minimum of 4 years of experience in a cGMP-regulated manufacturing environment or previous experience in a Quality Assurance or Quality Control role.
• Experience reviewing quality documentation and supporting material inspection, disposition, or release activities.
• Working knowledge of cGMP requirements, Good Documentation Practices, and quality system processes.
• Experience using Microsoft Office applications, including Word, Excel, and Outlook.
• Experience utilizing ERP systems to complete inventory movement transactions and maintain material records.
• Strong attention to detail with the ability to accurately review, document, and manage quality records.
• Excellent written and verbal communication skills.

Responsibilities

• Reviews and approves material inspection documentation and Manufacturing Process Specifications (MPS) to support material release activities.
• Supports and mentors QC Materials Inspectors I and II by providing technical guidance, training, and functional expertise.
• Coordinates annual retain inspections, facilitates required retesting activities, and ensures completion of all associated documentation within electronic and paper-based systems.
• Performs reverification activities for returned products in accordance with approved procedures.
• Reviews source inspection documentation, including third-party Device History Records (DHRs), to ensure compliance with applicable requirements.
• Participates in out-of-specification (OOS) investigations and supports material rejection investigations as required.
• Serves as the subject matter expert for material inspection processes and provides training for new employees, contractors, and Quality personnel.
• Authors, revises, and performs periodic reviews of standard operating procedures, Manufacturing Process Specifications, and related controlled documents.
• Initiates and completes Document Change Requests to support continuous improvement and ongoing compliance.
• Maintains accurate and complete records in accordance with Good Documentation Practices (GDP).
• Maintains training compliance for assigned procedures, systems, and quality processes.
• Supports internal audits, customer audits, and regulatory inspections by providing documentation, technical expertise, and inspection support.
• Participates in cross-functional projects and continuous improvement initiatives as assigned.

Skills

Attention to detail

Excellent written and verbal коммуника

Strong organizational skills

Effective communication

Education

High School Diploma or Equivalent

Tools

Microsoft Office

ERP systems

Job description

Anika Therapeutics, based in Bedford, MA, is seeking a Senior QC Incoming Inspector to lead material inspection and release activities for raw materials and components used in manufacturing. You will provide SME guidance, review documentation, and ensure GDP-compliant records with strong attention to detail.

The role requires at least 4 years in a cGMP-regulated environment, experience with MPS/DHRs, and proficiency in Microsoft Office and ERP systems.