Compliance Specialist

About the role

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

About the role

• Position Title: Engineering Compliance Specialist
• Location: Bedford, New Hampshire
• Department: Engineering
• Reporting To: Director, Engineering and Maintenance
• Responsible For (Staff): No

As the Engineering Compliance Specialist, you will play a pivotal role in ensuring the effective management and implementation of change controls, deviations, CAPA plans, and SOP updates within our sterile fill finish operations. You will collaborate with various departments to drive continuous improvement, maintain regulatory compliance, and enhance overall operational efficiency.

Essential Duties and Responsibilities

Change Control Management

• Initiate, review, and manage change control documentation related to equipment, processes, and systems.
• Facilitate cross-functional communication to ensure alignment with stakeholders and timely resolution of change requests.
• Conduct impact assessments to evaluate the potential effects of proposed changes on product quality, safety, and efficacy.

Deviation Handling

• Lead investigations into deviations, identifying root causes and implementing corrective and preventive actions.
• Collaborate with Quality Assurance, Manufacturing, and other relevant departments to develop comprehensive deviation reports.
• Ensure timely closure of deviations while maintaining compliance with regulatory requirements.

CAPA (Corrective and Preventive Action) Planning

• Develop and execute robust CAPA plans in response to identified issues or areas for improvement.
• Coordinate with cross-functional teams to implement corrective actions and preventive measures.
• Monitor and track CAPA effectiveness, making adjustments as necessary to enhance long-term performance.

Communication and Collaboration

• Act as a liaison between engineering, quality, manufacturing, and other relevant departments to ensure seamless communication and collaboration.
• Provide regular updates on change control, deviations, and CAPA status to management and relevant stakeholders.
• Foster a culture of proactive problem-solving and continuous improvement

Qualifications

Required: EXPERIENCE

• 2+ years' experience with GMP, ISO, and/or an FDA-regulated environment is required.
• Strong technical writer and SME in writing all Quality system documents (CAPAs, Deviations, Change Controls, SOPs, Reports, etc.)
• SME in investigation, root cause, and risk analysis in a cGMP environment for complex issues within the production environment
• Strong understanding of regulatory requirements, and industry best practices

Education

• Bachelor's Degree in a Science or Engineering related field preferred

Qualities

• Detail oriented with strong analytical and problem-solving capabilities
• Project management skills and the ability to drive initiatives to completion
• Excellent communication and interpersonal skills with the ability to work collaboratively across departments
• Assertive, self-directed, and results-oriented
• Honesty, integrity, respect, and courtesy with leadership and peers
• Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services.

• #LI-RS1
• Join us and be part of building the bridge between life changing therapies and patients. Let's talk future