Quality Control Incoming Inspector

Anika; Bedford (MA); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Discretionary bonus program

Comprehensive healthcare benefits

401(k) with up to 5% match

Employee stock purchase plan at 15% discount

Accrued paid time off

Job summary

Anika in Bedford, Massachusetts is seeking a QC Materials Incoming Inspector to ensure compliance with internal procedures and Good Documentation Practices in GMP manufacturing. The role involves inspecting incoming materials, conducting quality line clearances, and releasing raw materials for use.

The ideal candidate should have an associate's degree in Life Sciences and at least one year of QA/QC experience within a regulated environment. Strong communication skills and attention to detail are crucial for success in this position, along with familiarity with ERP systems such as SAP.

Qualifications

• Minimum of 1 year experience in a QA/QC role within a regulated industry.
• Ability to document activities accurately according to Good Documentation Practices.
• Experience in GMP manufacturing environments is a plus.

Responsibilities

• Perform incoming material inspections according to approved procedures.
• Release approved raw materials for GMP manufacturing use.
• Support continuous improvement initiatives and training for new employees.

Skills

Attention to detail

Organizational skills

Communication skills

Education

Associate's degree in Life Sciences

Tools

Microsoft Office

SAP

Job description

What You’ll Do

The QC Materials Incoming Inspector performs quality inspection and release activities for raw materials used in GMP manufacturing and packaging operations, ensuring compliance with internal procedures, specifications, and Good Documentation Practices. In this role, you serve as a subject matter expert in incoming material inspection, in-process packaging inspections, and material release activities within a regulated manufacturing environment.

How You’ll Contribute

• Perform incoming material inspections according to approved procedures, specifications, and quality requirements.
• Conduct quality line clearances and in-process inspections during inspection, packaging, and cartoning operations in accordance with SOP requirements.
• Release approved raw materials for GMP manufacturing and packaging use through completion of required documentation, status identification, and ERP inventory transactions.
• Update and maintain inventory transactions within SAP or equivalent ERP systems to support material control and traceability.
• Monitor annual retain inspections, coordinate required retesting activities with Quality Control, and complete associated documentation.
• Serve as a subject matter expert for incoming inspection activities and support training for new employees, contractors, and Quality personnel as needed.
• Document work activities in compliance with Good Documentation Practices and applicable quality procedures.
• Maintain current training qualifications for assigned procedures through classroom training, procedural review, and on-the-job training activities.
• Support continuous improvement initiatives and participate in additional projects and assignments as needed.

What It Takes

This role requires strong attention to detail, organizational skills, and the ability to perform quality inspection activities within a regulated manufacturing environment. The position exercises judgment in evaluating raw materials, packaging line conditions, and inspection results to ensure compliance with established specifications and procedures. Success in this role requires effective communication, accuracy in documentation, and the ability to manage multiple responsibilities while maintaining compliance and operational efficiency.

What You Bring

• Associate's degree in Life Sciences or equivalent combination of education and relevant work experience.
• Minimum of 1 year of experience in a QA/QC role within a regulated industry environment.
• Experience using Microsoft Office applications and ERP systems.
• Strong attention to detail and ability to follow established procedures and specifications.
• Ability to document activities accurately and maintain compliance with Good Documentation Practices.
• Strong organizational and communication skills.

Nice to Have

• Bachelor's degree in Life Sciences or related discipline.
• Experience working in cleanroom or GMP manufacturing environments.
• Experience using SAP or similar ERP systems within manufacturing or quality operations.
• Excellent written and verbal communication skills.

Compensation and Benefits

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. The role offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% match including immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, and additional long-term incentives such as stock awards.