Careers

Senior QA Compliance Specialist

Position Scope:

The Senior Quality Specialist works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements.  This position is a subject matter expert for cGMP documentation and policies, batch records, validation protocols and resolving non-conformances.

Strategic Focus Areas:

  • Design, implement and 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:

  • Coordinate with Manufacturing, Quality Control, Engineering and Facilities to meet customer and project requirements
  • Provide QA support for investigations including non-conformance, CAPA, root cause analysis, complaints, out-of-specification and environmental excursion
  • Review batch records and certificates of analysis for accuracy and completion prior to final release of product
  • Perform quality review of validation protocols and reports
  • Active participant in audits performed by customers and regulatory agencies
  • Assist in the development of training materials for QA staff
  • Maintain company compliance with national and international Quality System regulations
  • Assist in management of the Supplier Quality program
  • Participate in project teams and perform other duties as assigned

Job Complexity:

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.

Required Qualifications:

  • 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
  • Requires computer competence, including experience with database and Microsoft Office
  • Ability to interact positively and professionally with internal and external customers

Desired Experience, Knowledge, and Skills:

  • Quality System experience involving cGMP manufacturing and testing of textiles, gels, solids and liquid suspensions
  • 3+ yeas experience working with technology transfers
  • Ability to work autonomously, effectively manage time and deliver results on time
  • Ability to understand, resolve and document complex technical issues
  • Ability to perform Materials Master Data transactions in SAP
  • Experience in qualifying and managing suppliers
  • Excellent presentation skills, both written and in platform presentation format

 

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