Specialist I, Quality Compliance

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Job Summary

The Specialist I, GxP Compliance is responsible for representing Emergent in all aspects of regulatory inspections, internal and customer audits; including hosting and coordinating audits, inspection preparation and logistics; as well as preparing written responses, ensuring completion of all audit-related corrective actions.

The incumbant will be responsible for conducting Internal Audits, managing responses and CAPA’s as well as maintaining the regulatory surveillance system. This position is responsible for CGxP compliance (and all other applicable regulations) and supporting activities relating to these systems at the Winnipeg site.

In addition, this role provides oversight and manages complaints/inquiries, PAR’s and quality agreements

Responsibilities

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Plans, schedules and conducts internal quality system audits per audit schedule with no minimal oversight. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes and activities in creating the audit plan.
• As Lead Auditor for team based audits, oversees development, training and day to day audit activities throughout the audit. Responsible for diverse scope of audit activities, consolidating team audit notes and preparing comprehensive, thorough and concise audit reports.
• Analyze multiple, documents, records and observations, as well as interview personnel, to determine compliance to GxP regulations.
• Follow up with area management on audit responses and corrective actions and provide support as needed to clarify root cause analysis and appropriate corrective actions.
• Partner with Area Management to discuss findings, drive to consensus on resolution, corrective actions.
• Effectively negotiate difficult conversations on a routine basis.
• Verify corrective action effectiveness in accordance with regulatory expectations.
• Writes and revises Quality Technical Agreements.
• Work with Management to collect and analyze Compliance department metrics, attending Management Review meetings and presenting metrics and actions for Compliance Management as assigned.
• Actively supports Regulatory Inspection Process through participation during inspections and ensuring follow-up with management on inspection activities, as needed. Strong technical judgment, professional presence and advanced communication skills required.
• Maintain knowledge of quality and compliance regulations and standards to facilitate functioning as an internal subject matter expert, and provide compliance assessments when requested.
• Lead project teams as assigned. Provide compliance support and guidance as QA representative on assigned project teams
• Provide oversight and manage Emergent Winnipeg’s product inquiry and product complaint system
  
  

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• Bachelor’s degree in Science or related degree
• Minimum 5 years’ experience in the Pharmaceutical industry (or equivalent Life Sciences industry) with at least at least 4 years of experience within Quality Assurance
• Industry certifications or diplomas in Quality Management, Auditing, and/or Quality Systems considered an asset.
• Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
• Will have a fundamental understanding of quality philosophies, principles, systems, methods, tools, and standards.
• Experience with aseptic processes, clean room gowning, and Pharmaceutical quality system work preferred.
• Will be able to develop and implement quality programs including tracking, analyzing, reporting and problem solving.
• Ability to make sound decisions regarding high complexity compliance-related issues with low supervision.
• Strong judgment, critical analysis, critical thinking skills required.
• Ability to assess strengths and gaps of systems and processes.
• Must be able to multi-task, consolidate and analyze multiple documents simultaneously.
• High level of personal/departmental accountability and responsibility.
• Strong technical judgment, professional presence is required
• Strong Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP) and current industry trends.
  
  

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.