QA Compliance Specialist
An early-career quality role at Anika Therapeutics: the specialist reviews batch records and COAs, provides shop-floor QA support for cGMP medical device manufacturing, and assists with investigations, CAPAs, document control, and internal/customer/regulatory audits under ISO 13485. Fully on-site in Bedford, MA.
- Compensation
- Not disclosed
- Location
- Bedford, MA, Bedford, MA, US
- Work setup
- Onsite
- Seniority
- Intern
- Employment
- Internship
- Experience
- 0+ years
- Category
- Qa
- Posted
Skills
Must have
- 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 considered
- Basic computer proficiency, including 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 with cross-functional teams
- Fully on-site at the Bedford, MA facility
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
Full 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.
You’ll partner closely with Production and Quality Assurance to ensure documentation is accurate and complete, support investigations and corrective actions, and assist with internal, customer, and regulatory audits. This role is a great opportunity for an early-career quality professional to build hands-on experience in quality systems, manufacturing compliance, and product release activities.
This position is based at Anika’s Bedford, MA facility and is fully on-site.
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.