QA Compliance Specialist

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

What You’ll Do

As the QA Compliance Specialist, you’ll help ensure Anika’s manufacturing operations meet applicable quality, regulatory, and documentation requirements. Working in a regulated medical device and life sciences manufacturing environment, you’ll review production records, support shop-floor quality activities, and help maintain compliance with cGMP and ISO 13485 standards.

How You’ll Contribute

• Review batch records and Certificates of Analysis (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 Quality Assurance support to Production, including line clearances, in-process checks, and assistance with quality-related issues.
• Support investigations involving nonconformances, CAPAs, root cause analysis, product complaints, out-of-specification events, and environmental excursions.
• Provide Quality Assurance input and support for change controls and planned deviations.
• Provide document control support and help ensure quality documentation is maintained in accordance with applicable procedures and requirements.
• Issue and reconcile batch records to support manufacturing operations.
• Maintain Device History Records (DHRs) to ensure accurate and complete documentation of manufacturing activities.
• Support internal and external audits, including customer and regulatory audits, as part of the Audit Team.
• Assist in maintaining and improving the Quality System to support ongoing compliance with cGMP, ISO 13485, and internal quality requirements.
• Participate in cross-functional project teams and contribute to quality and compliance initiatives.
• Perform other related duties as assigned.

What It Takes

You’re detail-oriented, organized, and interested in building a career in Quality Assurance within a regulated manufacturing environment. You understand the importance of accurate documentation, following established procedures, and working collaboratively to maintain product quality and regulatory compliance. You’re comfortable managing multiple tasks, communicating with different teams, and learning new quality systems and processes.

What You Bring

• Bachelor’s degree, preferably in Life Sciences or a related discipline; relevant experience may be considered.
• 0–2 years of industry experience. Internship experience and familiarity with GMP and ISO requirements are considered.
• Basic computer proficiency, including experience with databases and Microsoft Office applications.
• Strong organizational skills and attention to detail.
• Good presentation skills.
• Excellent written and verbal communication skills.
• Ability to follow procedures, maintain accurate documentation, and work effectively with cross-functional teams.

Nice to Have

• Internship or previous experience in Quality Assurance, Quality Control, or another regulated manufacturing environment.
• Familiarity with cGMP requirements and ISO 13485 quality system standards.
• Exposure to batch record review, Device History Records, document control, nonconformances, CAPAs, or change controls.
• Experience supporting manufacturing floor activities, quality investigations, or internal and external audits.

This position is based at Anika’s Bedford, MA facility and is fully on-site.

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.