Hybrid Quality Assurance/Field Assurance Specialist bei AgNovos Healthcare

AgNovos is a biotechnology company that develops new treatments leveraging regenerative medicine to address persistent unmet medical needs related to bone disease. The Company was founded by Dr. James Howe, a renowned orthopedic surgeon who worked in clinical practice and research for more than thirty years.  The first therapeutic area that we are addressing is osteoporosis, a condition afflicting millions of people, especially women. The disease is characterized by lost bone volume and quality, reduced bone strength and increased fracture risk. In response to what many experts consider an osteoporosis crisis, AgNovos is working to transform the landscape of bone health.

The Quality Assurance (QA)/Field Assurance Specialist is responsible for supporting and maintaining the Quality Assurance and Field Assurance functions for the company. This role is expected to adhere to the execution of processes, methods, procedures and reporting standards for receiving, recording, evaluating, coordinating, communicating, and reporting on information related to safety and product performance events and trends that are potentially related to the company’s products and services.  More specifically, the QA/Field Assurance Specialist specializes in receiving, processing, analyzing, and reporting product complaints, safety events, and device deficiencies identified during clinical studies and commercial product use.  The position also coordinates the investigation and inspection of product issues, including, but not limited to, the management of potentially biohazardous materials returned from the end user. The position will also support the development, revision, and submission of safety reports required for regulatory compliance.  The position will also be assigned tasks and responsibilities to support general Quality Assurance/Quality Management System requirements. Quality Assurance activities will include, but not limited to, product inspection, nonconformance management, CAPA support, document control and records management, and production verification activities. The position will be located in the Rockville, MD office.

Essential Duties and Responsibilities:

Field Assurance:

• Support the global strategic business plan by assisting the Field Assurance Manager in developing and maintaining a company-wide comprehensive safety management/ field assurance program that keeps pace with the growth of the company.
• Assist with managing, monitoring and understanding AgNovos’ product quality and safety of products used in both clinical and commercial settings in order to i) ensure product safety and regulatory compliance with incident reporting requirements, ii) enhance existing systems and improve current work processes for safety surveillance and iii) analyze and respond to product related feedback and complaints.
• Assist with managing the administration and investigation of product complaints, safety events, device deficiencies, and work with Regulatory Affairs to support complaint reporting requirements to external regulatory agencies, as directed.
• Serve as an Unblinded Sponsor Representative (USR) for AgNovos-sponsored clinical studies that require sponsor blinding of safety and device performance data. 
• Support communications with AgNovos customers and key stakeholders for product and safety issues identified with distributed product.
• Support relevant safety reporting and remedial action activities for both clinical and commercial setting to ensure that all regulatory submissions and reports are in accordance with applicable regulations and requirements.
• Provide input into and adhere to the safety management plans established for sponsor-managed clinical studies.
• Assist in the preparation of performance metrics reporting to relevant company stakeholders regarding the status of events identified.
• Assist in performing trending analysis on field assurance data to identify problem areas that may require formal reporting/remediation.
• Assist in conducting periodic reviews and analysis of risks associated with the company’s products and “state of the art” to inform/update the risk management file associated with the company’s products.  This will include the preparation of MDAER assessment reports.

Quality Assurance:

• Manage the company’s QMS-related documentation, document change controls and QMS records management processes and maintains quality records storage provisions.
• Assist in the creation and management of design history files for the company’s products.
• Perform quality inspections of materials and products.
• Assist in the review of production records and assists in the release of accepted product/materials  and control of nonconforming product / materials.
• Assist in the management of nonconformance and CAPA activities and associated records.
• Assist in the preparation of quality-related presentations and associated data analysis for monitoring key performance metrics.
• Assist with QMS-related training for the company and assists in the management of training plans and training records for employees.
• Review and approve calibration and preventive maintenance records. 
• Assist in product labeling creation and control.
• Assist in Other QMS-related duties as assigned.

• Associate’s or bachelor’s degree preferred;  life sciences, engineering or related field preferred.
• No previous experience required.  1-2 years of experience in a GMP-regulated environment preferred.  Preferred experience with management of product complaints, safety events. device deficiencies and/or quality processes within the medical device or biotech industry.
• Ability to effectively manage multiple priorities, think analytically, and communicate effectively at all levels of an organization.
• Strong communication skills (technical writing, regulatory communications, HCP communications).
• Strong attention to detail; compliance focus.
• Adaptable to fast-paced, hands-on, entrepreneurial environment.

Physical Requirements:

• While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
• Specific vision abilities required by this job include close vision, distance vision.
• Office-based environment.
• Able to wear PPE when handling potentially biohazardous materials.

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

All your information will be kept confidential according to EEO guidelines.

Compensation & Benefits:

The salary range for this position is $60k-$75k annually.  Final salary will be determined based on several factors including market analysis, experience and internal equity.

AgNovos Bioscience offers a comprehensive suite of benefits including medical, dental, and vision coverage to a 401(k) plan with company match.  This position is on-site in the Rockville, MD office.