QA Compliance Specialist
Anika Therapeutics
Summary
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.
Job description
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.
Requirements
- 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.
Benefits
- Discretionary bonus program
- Comprehensive healthcare benefits
- Health savings account
- 401(k) plan with up to 5% company match
- Employee stock purchase plan at 15% discount
- Accrued paid time off
- Long-term incentives including stock awards
Company overview
Anika Therapeutics is a global joint preservation company specializing in early intervention orthopedic care. Founded in 1992 and headquartered in Bedford, Massachusetts, the company develops minimally invasive products that restore active living for patients worldwide. Anika focuses on high-opportunity spaces within orthopedics, including osteoarthritis pain management and regenerative solutions. The company's comprehensive portfolio leverages proprietary hyaluronic acid (HA) technologies to create innovative products such as viscosupplement injectables for OA pain management (Orthovisc, Monovisc, Cingal) and regenerative solutions for tissue repair (Hyalofast, Integrity, Tactoset). With operations spanning the United States, Italy, and global markets, Anika partners with clinicians to deliver meaningful advancements in orthopedic care, helping patients maintain mobility and quality of life through non-surgical and minimally invasive treatment options.