Senior QA Compliance Specialist

Job Title:        Senior Quality Assurance Compliance Specialist

Supervisor:    Quality Assurance Manager

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 closely with Manufacturing, Quality Control, Engineering and Facilities to meet customer and project requirements
  • Provide QA support of investigations, including nonconformance, CAPA, root cause analysis, complaints, out-of-specification and environmental excursion
  • Perform product releases and associated batch record reviews
  • Perform quality review of validation protocols and reports
  • Active participant in audits performed by customers and regulatory agencies
  • Assist in development of training materials for QA staff for current and new products
  • Maintain company compliance with national and international Quality System regulations for medical devices and pharmaceutical products by evaluating current procedures and practices
  • Participate in project teams and perform other related duties as assigned

Job Complexity:

Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance.


Required Qualifications:

  • Bachelor’s degree in the life sciences
  • 10 years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role
  • 5+ years of experience working in a high volume regulated commercial plant

Desired Experience, Knowledge, and Skills:

  • Advanced degree in the life sciences preferred
  • 3+ years of experience working on technology transfer team involving the qualification of manufacturing processes and methods
  • Experience with quality systems involving the cGMP manufacturing and testing of textiles, gels, solids, and liquid suspensions
  • Experience being the Quality Assurance project team representative involving tight timelines
  • Demonstrated experience writing, reviewing and approving quality policies and standard operating procedures
  • Ability to document, understand and resolve complex technical issues
  • Ability to handle multiple priorities and meet established deadlines

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