Program Coordinator, Standards Audits

PPTA, trade association for the plasma protein therapeutics industry, seeks a program coordinator to administer the audit scheduling and tracking for the standards certification programs of the Association, including the International Quality Plasma Program (IQPP) and Quality Standards for Excellence, Assurance and Leadership program (QSEAL).

The Coordinator will collaborate with Global Plasma team members and cross functionally to administer the audits programs. Responsibilities include, but are not limited to, processing certification/recertification applications, scheduling audits, reviewing audit reports, tasks related to PPTA's viral marker program and National Donor Deferral Registry, collaborating with related vendors, and contributing to further process automation.

Duties and Responsibilities

Standards Program (IQPP/QSEAL) Audit Processing:

Process new certification and recertification applications

Schedule audits with contracted auditors

Notify facilities and corporate contacts of scheduled audits

Notify corporate contacts of recertifications due

Follow-up with Senior Manager, Standards, on determination of audit review and certification status

Process all correspondence relating to applications, audit scheduling, observations and certification status

Order and issue certification/recertification recognition materials

Maintain physical and electronic files of all audits

Maintain audit databases, including updating facility and corporate contact data, audit status, billing status, observation tracking, etc.

Donor Deferral Registry:

Process NDDR/CDCS account requests with contracted vendor

In collaboration with the Senior Manager, work with vendor on NDDR/CDCS technical issues/updates

Process all related correspondence

Data reporting (Viral Marker, Residual Risk):

Learn data program application, collaborate with vendor as needed

Run and distribute required reports

Process all related correspondence

Other related tasks:

Review and approve invoices from auditors

Review and approve invoices from NDDR/CDCS vendor

Request invoices from Accounting for recertifications

Provide listings to Accounting as required for dues invoicing

Provide listings to communications for the Annual Report as requested

Communicate new certifications and recertifications to communications team for publication

Update certifications for website

Assist with app for audits report updates and other services as needed

Participate in auditor meetings and training as scheduled by Senior Manager, Standards

Review FDA/CBER website for Warning letters issued to IQPP certified members

Contribute to development of further automation of processes

Adhere to the Association's document retention policies

Qualifications

Education & Experience:

Minimum Bachelor's degree

At least 3 years of audit certification management/administration experience desired

Skills & Abilities:

Practical understanding standards certification process

Excellent verbal and written communications skills

Team player with excellent interpersonal skills

Ability to work cross-functionally and within a matrixed reporting scheme

Well-organized with ability to handle multiple projects and priorities

Ability to prioritize and set goals

Proficient computer skills, including MS Office 365, specifically, Access and Excel

Willingness to travel for business (10%)

Willingness and ability to occasionally work at the Annapolis, MD, office

Salary Range: $70k - $80k dependent upon individual qualifications

Benefits:

Group Health Plan

Vision

Dental

401k Savings Plan with Employer Match

Group Life/Disability

Fitness Program

Bonus plan

Hybrid Work (3 days in office)

How to Apply

Interested candidates are requested to submit their application by attachment to an e-mail to cizzi@, to the attention of Cathy Izzi.

Working at PPTA

PPTA maintains a respectful culture and environment that fosters inclusivity, diversity, collaboration, equity, and innovation, and reflects the global communities we serve. We encourage every team member to contribute innovative solutions toward meeting our goals and objectives in support of our Mission. We respect the work-life balance necessary for the best performance of each team member to drive broad and reliable access to high-quality plasma protein therapies, with a focus on the well-being of patients and plasma donors.

About PPTA

The Plasma Protein Therapeutics Association (PPTA) is the global industry trade association representing the private sector collectors of source plasma (plasma for manufacturing) and manufacturers of plasma-derived therapies.As a trusted partner to health systems, PPTA drives broad and reliable access to plasma derived medicinal products with a focus on the well-being of patients and plasma donors.These therapies are used by small patient populations worldwide to treat a variety of rare diseases and serious medical conditions.