QA Compliance Specialist

Anika Therapeutics•Bedford, MA

7d•$66,000 - $82,000•Onsite

About The Position

The QA Compliance Specialist helps ensure Anika’s manufacturing operations meet applicable quality, regulatory, and documentation requirements in a regulated medical device and life sciences manufacturing environment. The role reviews production records, supports shop-floor quality activities, and helps maintain compliance with cGMP and ISO 13485 standards. The Specialist works 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. The position is intended as an opportunity for an early-career quality professional to build hands-on experience in quality systems, manufacturing compliance, and product release activities. The role is based at Anika’s Bedford, Massachusetts facility and is fully on-site. Responsibilities also include supporting the maintenance and improvement of the Quality System and contributing to cross-functional quality and compliance initiatives. Other related duties may be assigned.

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.
Detail-oriented and organized, with an interest in building a career in Quality Assurance within a regulated manufacturing environment.
Ability to manage multiple tasks, communicate with different teams, and learn new quality systems and processes.

Nice To Haves

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.

Responsibilities

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.