Quality Assurance Regulatory Affairs Specialist

The Quality Compliance Specialist is responsible for aiding in the day-to-day responsibilities of the QMS administration for the Training, Investigation, Nonconformance, CAPA, Planned Deviations, Change Control, and internal auditing programs. This role is responsible for ensuring timely completion of investigations including root cause analysis and risk evaluation. The Quality Compliance Specialist works side by side with the Director of Quality Compliance to ensure quality system requirements are completed in a timely manner as defined by VERO procedures.

Essential Duties and Responsibilities

• Participate in Quality Investigations to complete NCRs, Planned Deviations, and CAPAs.

• Assist in the ongoing responsibilities of the QMS Training administration functions.

• Assist in the implementation and monitoring of compliance controls.

• Assist in the ongoing monitoring of the internal audit program.

• Assist in the monitoring of the Change Control program.

• Actively participate in the closure of investigations, root cause analyses, and implementation of corrective/preventive actions.

• Assist in the administration of quality documentation review, tracking, and trending.

• Maintain the administration of corrective/preventive actions stemming from investigations.

• Interface with all stakeholders for technical assistance and problem-solving areas of quality compliance-related tasks.

• Identify and escalate any compliance issues/gaps and their potential impact across VERO Biotech to drive towards effective resolution.

• Provide guidance and training, as required for NCR, Deviation, and CAPA owners to effectively manage each program. Additionally, provide applicable problem-solving tools with required standards and regulations, VERO Biotech policies, procedures, and work instructions to owners.

• Ensure timely completion of investigations in accordance with established company timelines.

• Participate in routine internal audits of GMP systems.

• Aide in ensuring maintenance of a robust training program including authoring of SOP’s and identifying improvements to existing programs.

• Monitor KPIs and perform data trending for quality metrics.

• Review and provide input for revisions to SOPs following assessments of systems and through conducting of investigations.

• Participate in continuous improvement objectives to assure compliance with regulations.

• Practices and promotes Good Manufacturing Practices.

• Other duties as assigned.

• Bachelors degree or equivalent work experience preferred.
• High School Diploma or GED required.
• Experience in the Medical Device and/or Pharmaceutical industry including knowledge of FDA and ISO and other related industry regulations preferred (i.e.: 21CFR820, 210, 211, ISO 13485, ISO 14971).
• Demonstrated organizational and communication skills.
• Proven ability to manage priorities and workflow and handle multiple projects and meet deadlines.
• Ability to work independently and as a member of various teams and committees.
• Ability to deal effectively with diverse group of individuals at all organizational levels.
• Exceptional writing and interpersonal relationship skills
• Experience with direct contact with FDA and other regulatory bodies
• Good judgement with the ability to make timely and sound decisions.
• Creative, flexible, and innovative team player.

Supervisory Responsibilities

• N/A

   Competencies

• Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.

• Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

• Change Management—Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results

• Quality Management--Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

  Physical Demands and Work Environment

• Standard office and laboratory environment