Quality Management/Regulatory Affairs Specialist

Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site.

Responsible for new product setup, quality project management, and regulatory compliance of serum products.

Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import/export regulations, etc.

New product setup and management of related projects

Assist with Supplier audits, as needed

Maintenance of BSE Serum Certificates of Suitability filing with EDQM

Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.

Serve as a resource for customer's regulatory and technical inquiries

Ongoing maintenance of ISO 13485 based quality system

Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution.

Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.

Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.

Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.

Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.

Assists in representing in customer quality audits, supplier quality audits and regulatory inspections

Performs investigations and analysis activities to support resolution of quality issues.

Collaborates with organizational teams to support quality system implementation.

Creation of new product master files satisfying customer and quality system requirements

Ensures quality standards by following company & departmental policies & procedures including, but not limited to

o Product performance & quality verification.

o Identifying, recording, and investigating problems related to product, process & quality systems.

o Evaluating processes for improvements and standardization.

o Initiating action to prevent non-conformance in products, process, and quality systems.

Training on quality systems and applicable regulations as identified by supervisor and required by position.

Tracking/trending aspects of the QMS.

Minimum of Bachelor's degree in Science, Engineering, Bioengineering or related field. Prefer

Chemistry or Biology degree programs.

Minimum 3 years' experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry.

Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485

Ability to develop, update and train on SOPs.

Working knowledge of ISO standards and Quality Management Systems (QMS).

Problem solving techniques to perform investigations and drive root cause analysis.

Related work experience performing internal/external audits.

Ability to monitor the QMS such as: Change Control, CAPA, Complaints,

Nonconforming Materials and Products.

Experience with Continuous Improvement, Lean or Six Sigma.

SAP, EtQ and/or PeopleSoft experience.

Experience with statistical analysis.

Project management experience.

Animal by-product import/export regulations

Animal health and/or virology, immunology, epidemiology knowledge

Ability to multi-task with ability to be organized.

Strong interpersonal and communication skills.

Strong time management skills and attention to detail.

Ability to influence others in a team environment while collaborating with peers and

functional areas.

Ability to work independently with minimal supervision