- Working across multiple functions, participate in the implementation and maintenance of the site's quality system framework and regulatory inspection, including PAI readiness, support by coordinating and tracking activities of the quality systems requirements and processes.
- Support the tracking, trending, and analysis of quality processes and systems across the product lifecycle including, but not limited to: PAI readiness, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
- Support Tech Ops supplier management by facilitating the assessment, qualification, and approval of suppliers.
- Participate in or lead internal self-assessment audits.
- Proactively identify and work collaboratively to resolve problems. Supporting risk-based and compliant approaches to solutions.
- Working across functions to ensure compliant document control and training programs.
- Support organizing technical documentation needed for regulatory submissions.
- Work with stake holders on audit management in Dot Compliance
- Lead or participate in Quality Risk Management and Data Governance Processes as needed.
- Participate in activities to support regulatory agency inspections, including developing a process to quickly communicate inspector's needs and provide the appropriate documentation.
- Support site objectives with a minimal amount of supervision. Includes simple project management that may involve other functional areas.
- Promote a quality mindset and quality excellence approach to all activities.
- Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
- Travel is limited (at least quarterly) but may occasionally be required.
Basic Qualifications and Capabilities:
- 2+ years' experience working directly with Project Management in the pharmaceutical or medical device or healthcare industries. Appropriate combinations of experience and education.
- Demonstrated experience conducting and writing compliance and/or risk assessments.
- Project management, word processing skills, organization, and execution skills are required.
- Ability to apply expertise to solve problems and issues.
- Participating in and leading activities that support regulatory agency inspections is required.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills, and share knowledge with others.
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