Supervisor, QA – Incoming Inspection

Position Scope:

The Supervisor of Quality Assurance assures consistent quality of production according to medical device and drug regulations by ensuring quality practices are efficient while enforcing current good manufacturing practices (cGMP).

The Supervisor of QA Incoming Inspection has the primary responsibility for supporting incoming materials inspection, review and release. Have oversight of the incoming inspector staff. The position oversees and executes the daily, short term and long term activities and goals associated with the release of incoming materials by ensuring Deviations, CAPAs and Change Controls associated with specific lots are properly documented and closed if needed prior to materials release. This individual will work with Operations, Facilities, Manufacturing, Quality Assurance and other departments to ensure cGMP compliance, meet company production goals, provide opportunities for training and growth for employees, and ensure the optimization of safety, production, quality, and results.

Strategic Focus Areas:

• Provide leadership for quality compliance activities, and corporate initiatives.
• Optimize resources within assigned area to maintain compliance standards.
• Support optimization of the global quality system through integration of or cooperation with other Anika sites’ quality systems.
• 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:

• This is a hands-on position with managerial responsibilities of the incoming materials inspection staff while maintaining Anika’s established quality systems.
• Ensures company compliance is maintained, considering Anika’s standard operating procedures and practices according to current regulations in accordance to 21 CFR 820, ISO 13485, ICH, CMDR and MDD and EU MDR.
• Supervises staff within the incoming materials function and recruit, train, coach, counsel, discipline employees, review job descriptions, and recommend compensation based on employee performance consistent with internal Human Resource policies.
• Organizes department activities to consistently meet supply chain and customer service schedules involving completion of incoming materials inspection, resolving nonconformities, and providing necessary documentation for materials release.
• Ensures quality line clears and in process inspections are performed during inspection and packing processes according to specific SOP requirements.
• Assists with the creation of material numbers in the ERP system (SAP) and updates material master as requested.
• Reviews material specifications to ensure data meets industry requirements for data integrity.
• Performs investigations requiring the identification of root cause involving product impact assessments using a risk based approach involving scientific information, input from subject matter experts, and historical data.
• Responsible for leading the team in completion of a routine and non-routine tasks including updating and approving material specifications, procedures and other related documentation.
• Monitor and ensure annual retain inspection is performed; coordinate required retesting with QC; complete required documentation.
• Develops, implements and assesses process and policies designed to make incoming inspection process and release more efficient
• Meets Quality Assurance financial objectives by implementing efficiencies, assisting in the preparation of annual budget, and correcting budgetary variances.
• Provides support during customer and compliance audits involving the preparation of Quality documentation and the review of requested information with auditors.
• Prepares and presents monthly and quarterly metrics of materials received and released.
• Support performance of monthly walkthrough audit of the facilities as scheduled and ensure corrective actions related to incoming inspection area are implemented.
• Perform biennial review for designated procedures and MPS as needed.
• Responsible for other duties and projects as assigned.

Job Complexity:

Assignments are defined by objectives 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 national and international regulations and regulatory guidance. Good understanding of scientific and engineering principles.

Managerial Responsibilities:

Supervises Quality Assurance with focus on Incoming Inspection of Materials and QA in-process inspection of packaging activities.

Required Qualifications:

• Bachelor’s Degree in a technical or scientific discipline or related previous experience.
• Demonstrated knowledge of regulated medical device industry including experience with FDA Quality System Regulation, current ISO 13485, cGMPs, and EU MDD and EU MDR.
• Seven to ten years of increasingly complex Quality Assurance experience in a commercial medical device company

Desired Experience, Knowledge, and Skills:

• Bachelor’s degree in science degree is strongly preferred
• Demonstrated experience building strong partnerships with Operations and Quality Control departments.
• Previous aseptic manufacturing experience.
• Knowledge of SAP Material Master and other Quality functions within SAP.
• Demonstrated experience delivering results in a fast paced, hands-on organization requiring high energy
• Ability to work autonomously, effectively manage time and deliver results on time
• Good presentation skills, both written and in platform presentation format