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 and requires a working knowledge of cGMP, FDA QSR, ISO 13485 standards and EU MDR.
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:
- Oversee CAPA, change controls, internal audits and monitor timely completion and closure.
- Schedule and hold monthly CAPA and change control meetings with meeting minutes generated as output.
- Schedule, assign, perform internal audits and track implementation of internal and external audits observations for on time closure
- Ensure quality trends and respective observations are documented and escalated in accordance with company procedures.
- Prepare KPI reports as an input to the Quality Metrics and Management Reviews
- Provide QA support for investigations including non-conformance, CAPA, root cause analysis, out-of-specification, environmental excursion and calibration.
- Coordinate with Manufacturing, Quality Control, Engineering and Facilities to meet customer and project requirements.
- Contribute to development, review and revision of procedures in accordance with the Quality Management System (QMS).
- Maintain the device history files (DHF) as applicable.
- Update, review and approve changes to the device/drug master files (DMR)
- Active participant in audits performed by customers and regulatory agencies by assisting with audit scheduling, preparation and set-up, providing documentation, and other audit and post-audit activities as needed.
- Ensure all activities are performed according to internal Quality System requirements.
- As needed, review batch records and certificates of analysis for accuracy and completion prior to final release of product
- As needed, coordinate product releases with distributors and customers
- As needed, perform review of Quality Control laboratory tests, results, protocols and reports
- Assist in the development of training materials for QA staff
- Maintain company compliance with national and international Quality System regulations
- Participate in project teams and perform other duties 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, FDA, EU, ISO requirements, specifically ISO 13485 Medical Devices and EU MDR
- Experience auditing in a GMP/ISO/MDSAP/EU MDR environment
- Requires computer competence, including experience with database and Microsoft Office
- Ability to interact positively and professionally with internal and external customers
- Excellent written and verbal communication skills
- Excellent presentation skills, both written and in platform presentation format
Desired Experience, Knowledge, and Skills:
- Quality System experience involving cGMP manufacturing and testing of textiles, gels, solids and liquid suspensions
- 3+ years’ experience working with technology transfers
- Demonstrates efficiency in managing processes on paper and in the electronic quality management system (eQMS)
- Ability to work autonomously, effectively manage time and deliver results on time
- Ability to understand, resolve and document complex technical issues
- Good organization skills
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.