Senior QA Compliance Specialist
The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The position will provide floor support to production departments to include line clearances, in-process checks and assistance with investigations. The Senior Compliance Specialist also performs audits as assigned, and participates in customer and regulatory audits as part of the Audit Team. All activities are performed according to internal Quality System requirements, cGMP and ISO 13485 standards.
Strategic Focus Areas:
- Participate in projects and activities which support the top and bottom line growth of the company through compliant improvement activities.
- Provide leadership for quality compliance activities and initiatives.
- Create a positive image of Anika Therapeutics through communication and interaction with key stakeholders including employees, customers, partners, vendors, and appropriate government and regulatory authorities.
Specific Tactical Responsibilities:
- Review and approve supplemental logs, charts and other documents in support of cGMP operations.
- Review batch records and certificates of analysis for accuracy and completion prior to final release of product.
- Maintain the Approved Supplier List including updating and reviewing performance of vendors.
- Provide quality assurance support of investigations including: nonconformance, CAPA, root cause analysis, complaints, out of specification and environmental excursions.
- Provide quality input and maintain the files for change controls and planned deviations.
- Provide document control support.
- Issue and reconcile batch records.
- Maintain device history files.
- Perform internal and external audits as assigned.
- Assist in the maintenance and implementation of the Quality System.
- Perform Material Master data transactions in the ERP system, specifically SAP.
- Participate in project teams and perform other related duties as assigned.
- Responsible for other duties and projects as assigned.
Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires current knowledge of all applicable international regulation and regulatory guidance.
- Bachelor’s Degree required, preferably in the life sciences or relevant experience.
- 5+ years industry experience in a QA function.
- Knowledge of GMP/ISO requirements, specifically ISO 13485 Medical Devices.
- Experience auditing in a GMP/ISO environment.
Desired Experience, Knowledge, and Skills:
- Ability to interact positively and professionally with internal and external customers.
- Ability to work autonomously, effectively manage time and deliver results on time.
- Ability to perform Materials Master Data transactions in SAP.
- Requires proficiency in word processing, spreadsheets, and databases.
- Excellent presentation skills, both written and in platform presentation format.