Senior QC Incoming Inspector

Anika; Bedford (MA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Discretionary bonus program

Comprehensive healthcare benefits

Health savings account

401(k) plan with company match

Employee stock purchase plan

Paid time off

Job summary

Anika is seeking a Senior QC Incoming Inspector in Bedford, MA to lead material inspection, disposition, and release activities for raw materials and components used in manufacturing. You will ensure regulatory compliance and provide expert guidance on GDP and quality system processes.

You will mentor QC Inspectors, review MPS and DHRs, and drive documentation accuracy while supporting audits and continuous improvement initiatives across the site.

Qualifications

• This role requires a high school diploma or equivalent; additional technical education is preferred.
• Minimum 4 years in a cGMP-regulated manufacturing environment or QA/QC role.
• Experience reviewing quality documentation and material inspection, disposition, or release activities.
• Working knowledge of cGMP, GDP, and quality system processes.
• Proficiency with Word, Excel, and Outlook; ERP usage for inventory movements.

Responsibilities

• Reviews and approves material inspection documentation and MPS for material release.
• Mentors QC Materials Inspectors I and II with guidance and training.
• Coordinates annual retain inspections and required retesting activities.
• Performs reverification for returned products per procedures.
• Reviews source inspection docs including DHRs for compliance.
• Participates in OOS investigations and material rejection investigations as needed.
• Authors and revises SOPs, MPS, and controlled documents.
• Initiates Document Change Requests for improvements.
• Maintains GDP-compliant records and training for procedures.
• Supports internal and regulatory audits with documentation and inspection input.
• Contributes to cross-functional projects and continuous improvement.

Skills

Attention to detail

Excellent communication

Strong organizational skills

Ability to balance priorities

Education

High school diploma or equivalent

Technical/scientific education preferred

Tools

Microsoft Office

ERP systems

Job description

What You'll Do

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.

How You'll Contribute

• 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.

What It Takes

This role requires a strong understanding of quality control systems, material inspection processes, and cGMP requirements within a regulated manufacturing environment. The position exercises sound judgment when reviewing materials, documentation, and quality records to ensure only compliant materials are approved for use in manufacturing. Success in this role requires attention to detail, strong organizational skills, effective communication, and the ability to balance multiple priorities while maintaining compliance and supporting operational objectives.

What You Bring

• 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 Have

• 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.

The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location.

• Anika also offers a discretionary bonus program for all full-time employees.
• comprehensive healthcare benefits.
• health savings account.
• 401(k) plan with up to 5% company match which includes immediate vesting.
• employee stock purchase plan at a 15% discount.
• accrued paid time off.
• additional long-term incentives including stock awards.
• and much more.

At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

M-F 8:00am - 4:30pm