GMP Auditor - Aseptic Processing (Contract)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The GMP Auditor will be responsible for planning and conducting GMP audits (qualification, re-qualification, for-cause, and PAI readiness) on behalf of clients. The position of GMP Auditor will also act as a Subject Matter Expert (SME) for GMP auditing and supplier management projects and will be responsible for supporting the development and management of the GMP auditing program.
This position is responsible for independently managing GMP auditing projects and providing consulting services to clients as needed. The GMP Auditor will ensure compliance with ProPharma Group’s GMP auditing program, policies, and strategies, ensuring company adherence to GMP regulations, internal procedures, and policies in cooperation with peers.
Essential Functions:
•    Serve as a subject matter expert (SME) for GMP auditing – Aseptic Processing projects within ProPharma Group, with a specific focus on sterile compounding, aseptic processing, and sterility assurance.
•    Execute audits based on experience and a comprehensive understanding of all federal regulatory requirements, including USP <797>, FDA aseptic processing guidelines, and ICH (International Council for Harmonization) guidance.
•    Conduct audits of sterile compounding facilities, cleanrooms, and aseptic processing environments, assessing compliance with regulatory requirements and industry best practices.
•    Evaluate cleanroom behavior, personnel gowning, environmental monitoring, and contamination control practices during audits.
•    Assess sterility assurance practices, including validation of aseptic processes, media fills, and sterilization methods.
•    Contribute to the implementation of a risk-based GMP audit program, incorporating considerations for sterile product manufacturing and compounding.
•    Provide support to clients and all functional units of ProPharma Group regarding supplier management and GMP auditing issues, including deviations and non-conformances.
•    Provide consultation for the implementation of corrective and preventive actions (CAPA) to resolve deviations and non-conformances.
•    Ensure compliance of company operations with quality principles and participate in the development of quality systems through SOP writing and training.
•    Promote GMP supplier management and auditing subject expertise through publications and presentations via professional networks.
•    Provide ongoing support and expertise to all personnel, assisting them in establishing goals, objectives, policies, and procedures for all applicable subsets of this business unit within the company.
•    Ensure consulting practices are in compliance with all applicable internal and external policies, procedures, and industry best practices.
•    Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively and to meet revenue and profit goals based on personnel skills development and client needs.
•    Audit supplier management and GMP auditing projects for correct approach, consistency, and quality.
•    Interact in a professional and positive manner with clients and co-workers.
Required Characteristics:•    B.S./B.A. in a scientific discipline; a graduate degree in a scientific discipline is preferred.•    Quality orientation and high attention to detail.•    Strong working knowledge of international cGMP requirements and standards.•    In-depth knowledge of USP <797>, FDA aseptic processing guidelines, and best practices for sterile compounding and aseptic manufacturing.•    Experience conducting audits of sterile product manufacturing, aseptic processing facilities, and cleanroom environments.•    Understanding of contamination control, personnel gowning requirements, environmental monitoring, and sterility assurance principles.•    Ability to apply expertise in quality systems, data integrity, software compliance, and GMP requirements to conduct audits and provide gap analyses and risk assessments for clients.•    Strong editorial skills for the review and approval of GMP documentation, including protocols, reports, and SOPs.•    Effective written and oral communication skills, with the ability to convey information and instructions accurately.•    Minimum of 5 years of supplier management and GMP auditing experience in a related industry, with specific experience in sterile manufacturing and aseptic processing.•    Ability to interact professionally and positively with clients and co-workers.•    Strong persuasion and presentation skills.•    High-level understanding of supplier selection criteria and GMP auditing services in the pharmaceutical, medical device, and biotech industries.•    Ability to successfully earn and maintain client confidence through appropriate project planning, organizing, controlling, and directing.•    Proven record in team leadership, problem-solving, project tracking and budgeting, and facilitating efficient client-team communication.•    Experience working with high-performance teams and managing multiple projects.•    Ability to think ahead and develop action plans to achieve results.•    Supervisory experience, including employee hiring and retention, performance review, and discipline.•    Ability to balance and achieve positive results in the areas of safety, quality, productivity, cost, and employee relations.•    Excellent analytical skills with the ability to assess and resolve complex business and compliance situations.