Senior QA Compliance Specialist

Position Scope:

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 Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier audits as assigned, participates in customer and regulatory audits as part of the Audit Team, Maintain the Design History Files (DHF), Design Master Records (DMR), track implementation of internal and external and supplier audits observations for on time closure and is the SME trainer of junior QA personnel. All activities are performed according to internal Quality System requirements, cGMP, current ISO 13485 standards as well as other regulatory requirements such as EU, FDA, TGA, and ANVISA.

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:

Review batch records and certificates of analysis for accuracy and completion prior to final product release.

Responsible for nonconformance and planned deviations investigations review and approval including root cause analysis, tracking and trending for on time closure. Maintain associated tracking logs.

Responsible for out of specification and environmental excursion investigations review, approval, tracking and trending for on time closure.

Manage the CAPA and Change Control programs as assigned and maintain associated tracking logs.

Maintain the Approved Supplier List including updating and reviewing performance of vendors.

Responsible for the maintenance the Design History Files (DHF) and Design Master Records (DMR).

Perform QA review of new and revised procedures, technical protocols, validations and reports as assigned.

Perform internal and external audits as assigned including internal Quarterly Walkthroughs.

Manage the facility monthly walkthroughs program performed by other departments, ensuring follow up for correction action implementation, on time closure and trending.

Responsible for Material Master data transactions in the ERP system, specifically SAP.

Provide floor support to production departments to include line clearance and in-process checks as needed.

Assist in the maintenance of the Quality System.

Participate in project teams and perform other related duties as assigned.

Provide document control support.

Issue and reconcile batch records

Responsible for other duties and projects 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 national and international regulations and regulatory guidances.

Supervisory Responsibilities:

None

Required Qualifications:

Bachelor’s Degree preferably in the life sciences or equivalent experience

5+ years industry experience in a QA function.

Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.

Knowledge of the FDA 21CFR, EU, TGA (Australia), ANVISA (Brazil) regulatory requirements.

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