QA Compliance Specialist – Regulated Med Devices

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

Health savings account

401(k) with company match

Employee stock purchase plan

Paid time off

Stock-based incentives

Job summary

Anika Therapeutics, Inc. in Bedford, MA seeks a QA Compliance Specialist to help ensure manufacturing operations meet quality, regulatory, and documentation requirements.

You’ll review production records, support shop-floor quality activities, and help maintain compliance with cGMP and ISO 13485 standards. The role involves supporting nonconformance investigations, CAPAs, change controls, and audits, while maintaining thorough Device History Records and documentation practices in a fully on-site

Qualifications

• Bachelor’s degree in Life Sciences; relevant experience may be considered.
• 0–2 years of industry experience; GMP/ISO familiarity is a plus.
• Basic computer proficiency with databases and MS Office.
• Strong organizational skills and attention to detail.
• Good presentation and excellent written/verbal communication.
• Ability to follow procedures and maintain accurate documentation with cross-functional teams.

Responsibilities

• Review batch records and COAs for accuracy and completeness prior to final product release.
• Review and approve supplemental logs, charts, and other documentation supporting cGMP manufacturing operations.
• Provide shop-floor QA support to Production, including line clearances and in-process checks.
• Support investigations involving nonconformances, CAPAs, root cause analysis, product complaints and out-of-spec events.
• Provide QA input for change controls and planned deviations.
• Documentation control support and ensure adherence to procedures.
• Issue and reconcile batch records to support manufacturing operations.
• Maintain Device History Records (DHRs) for complete manufacturing documentation.
• Support internal and external audits as part of the Audit Team.
• Help maintain and improve the Quality System for ongoing compliance with cGMP/ISO 13485.

Skills

Attention to detail

Communication skills

Organizational skills

Documentation skills

Cross-functional collaboration

Basic computer skills

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Databases

Job description

Anika Therapeutics, Inc. in Bedford, MA seeks a QA Compliance Specialist to help ensure manufacturing operations meet quality, regulatory, and documentation requirements.

You’ll review production records, support shop-floor quality activities, and help maintain compliance with cGMP and ISO 13485 standards. The role involves supporting nonconformance investigations, CAPAs, change controls, and audits, while maintaining thorough Device History Records and documentation practices in a fully on-site