Senior QC Incoming Inspector
Anika
August 31, 2026
On-site
Bedford, MA
$28 - $35 USD yearly
Operations
Senior QC Incoming Inspector
Responsibilities:
- Review and approve material inspection documentation and Manufacturing Process Specifications (MPS) for material release.
- Support and mentor QC Materials Inspectors I and II with technical guidance and training.
- Coordinate annual retain inspections and retesting; ensure completion of documentation in electronic and paper systems.
- Perform reverification for returned products per approved procedures.
- Review source inspection documentation (including third-party Device History Records) for compliance.
- Participate in out-of-specification (OOS) investigations and support material rejection investigations.
- Serve as subject matter expert for material inspection processes; train new employees/contractors/Quality personnel.
- Author, revise, and periodically review SOPs, MPS, and controlled documents.
- Initiate and complete Document Change Requests.
- Maintain accurate records per Good Documentation Practices (GDP).
- Maintain training compliance for assigned procedures/systems/quality processes.
- Support internal, customer, and regulatory audits/inspections with documentation and technical expertise.
- Participate in cross-functional projects and continuous improvement.
What it takes (Required):
- High school diploma or equivalent (technical/scientific education preferred).
- Minimum 4 years in a cGMP-regulated manufacturing environment, or prior QA/QC experience.
- Experience reviewing quality documentation for inspection/disposition/release.
- Working knowledge of cGMP, GDP, and quality system processes.
- Microsoft Office (Word/Excel/Outlook).
- ERP experience for inventory transactions and material records.
- Strong attention to detail; excellent written/verbal communication.
Nice to have (Preferred):
- Cleanroom/controlled environment experience.
- Experience with regulatory inspections and customer audits.
- OOS/material rejection/corrective action knowledge.
- Controlled document authorship/revision (SOPs/specs).
- Independent work; manage competing priorities and deadlines.
- Training/mentoring experience.
Benefits (as stated): discretionary bonus; comprehensive healthcare; HSA; 401(k) up to 5% match; employee stock purchase plan; paid time off; long-term incentives/stock awards.
Responsibilities:
- Review and approve material inspection documentation and Manufacturing Process Specifications (MPS) for material release.
- Support and mentor QC Materials Inspectors I and II with technical guidance and training.
- Coordinate annual retain inspections and retesting; ensure completion of documentation in electronic and paper systems.
- Perform reverification for returned products per approved procedures.
- Review source inspection documentation (including third-party Device History Records) for compliance.
- Participate in out-of-specification (OOS) investigations and support material rejection investigations.
- Serve as subject matter expert for material inspection processes; train new employees/contractors/Quality personnel.
- Author, revise, and periodically review SOPs, MPS, and controlled documents.
- Initiate and complete Document Change Requests.
- Maintain accurate records per Good Documentation Practices (GDP).
- Maintain training compliance for assigned procedures/systems/quality processes.
- Support internal, customer, and regulatory audits/inspections with documentation and technical expertise.
- Participate in cross-functional projects and continuous improvement.
What it takes (Required):
- High school diploma or equivalent (technical/scientific education preferred).
- Minimum 4 years in a cGMP-regulated manufacturing environment, or prior QA/QC experience.
- Experience reviewing quality documentation for inspection/disposition/release.
- Working knowledge of cGMP, GDP, and quality system processes.
- Microsoft Office (Word/Excel/Outlook).
- ERP experience for inventory transactions and material records.
- Strong attention to detail; excellent written/verbal communication.
Nice to have (Preferred):
- Cleanroom/controlled environment experience.
- Experience with regulatory inspections and customer audits.
- OOS/material rejection/corrective action knowledge.
- Controlled document authorship/revision (SOPs/specs).
- Independent work; manage competing priorities and deadlines.
- Training/mentoring experience.
Benefits (as stated): discretionary bonus; comprehensive healthcare; HSA; 401(k) up to 5% match; employee stock purchase plan; paid time off; long-term incentives/stock awards.