Senior QC Incoming Inspector

Anika Therapeutics•Bedford, MA

1d•$28 - $41•Onsite

About The Position

The Senior QC Incoming Inspector supports quality control activities related to the inspection, approval, and release of raw materials and components used in product manufacturing, as well as inspection activities associated with in-process manufacturing and packaging operations. In this role, you serve as a subject matter expert in material inspection, material disposition, documentation review, and quality system compliance, ensuring materials and records meet established quality and regulatory requirements.

Requirements

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.

Nice To Haves

Experience working within a cleanroom or controlled manufacturing environment.
Experience supporting regulatory inspections, customer audits, and quality system assessments.
Knowledge of OOS investigations, material rejection processes, and corrective action activities.
Experience authoring and revising controlled documents, including SOPs and manufacturing specifications.
Ability to work independently, effectively manage competing priorities, and consistently meet deadlines.
Experience training and mentoring quality personnel in inspection processes and quality system requirements.

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.