Looking to Grow with a Company? Sr. QA Specialist Miami, FL · Full time

The Senior Quality Assurance Specialist, Donor Eligibility facilitates tissue supply chain operations by verifying donor eligibility and maintaining required donor documentation. This role is responsible for overseeing blood and tissue collection operations to ensure compliance with established procedures, standards, and regulations. The Sr. QA Specialist partners with functional groups as the point of contact for quality issues associated with donor operations and fosters continuous improvement of blood and tissue supply chain operations.

Description

Essential Functions:

  • Serves as the primary QA point of contact for all donor and collection quality-related issues.
  • Verifies and documents donor eligibility and approval to participate in blood and tissue donation programs.
  • Works cross-functionally to ensure the timely release of tissue-related products.
  • Approves and issues conditional and final C of A in support of product release.
  • Monitors donor engagement activities and tissue collection operations to ensure compliance with internal procedures and applicable regulations.
  • Performs timely reviews of donor charts, informed consents, donor history questionnaires, and related donor documentation.
  • Interacts with Medical Director on donor history questionnaires, and related donor documentation eligibility questions as applicable.
  • Reviews and approves donor deferral documentation.
  • Manages donor enrollment databases and tracks donor participation.
  • Writes, revises, and implements regulatory-compliant quality policies and procedures.
  • Trains staff on quality-related processes and procedures, including annual compliance training.
  • Ensures controlled issuance, distribution, retrieval and archival of controlled documents and records.
  • Verifies, issues, and ensures reconciliation of product and sample labeling.
  • Facilitates internal audits of tissue supply chain operations.
  • Conducts and documents deviations and investigations, as needed, and ensures successful completion of associated CAPAs.
  • Assists in the development of material specifications, ensures material CoA/CoC documentations is available, and performs release of incoming raw materials.
  • Ensures new and existing physicians are appropriately onboarded and all required documentation is on file and current.
  • Manages and maintains donation program documentation.
  • Prepares annual donor reports for submission to IRB.
  • Assists in the facilitation of partner/customer audits and regulatory inspections.
  • Participates in supplier audits, as needed.


Non-Essential Functions:

·        Other related duties as assigned.


Position Qualifications:

Competencies:

·        Consistently sets a high standard for quality of work.

·        Comfortable with working in a fast-paced and dynamic start-up environment.

·        Ability to work flexible hours to meet business and/or customer needs.

·        Excellent interpersonal, organizational, communication and listening skills.


Skills and Abilities:

Education: Bachelor’s degree in science or equivalent industry experience.

Experience: 5+ years of experience working in a GxP environment or other regulated industry. Prior experience in a donor-focused quality role, strongly preferred. Experience with apheresis, whole blood, placenta, umbilical cord- and cord blood-derived products is preferred. Experience supporting internal, regulatory, and partner audits is preferred.

Computer Skills: Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams. Familiarity with electronic documentation systems a plus.

Certificates & Licenses: N/A.

Other Requirements: Familiarity with cGTP and cGMP requirements, specifically 21CFR 606, 630 and 1271, as well as AABB and AATB requirements. AABB and/or AATB certification is preferred. CPR training is preferred. It is preferred that successful applicants for this position to be fully vaccinated against COVID-19 and Hep B.


OrganaBio is an Equal Employment Opportunity employer. OrganaBio prohibits any form of unlawful harassment or discrimination against applicants for employment or employees on the basis of any legally protected status entitled to protection under federal, state, or local law.


DISABILITY ACCOMMODATION FOR EMPLOYMENT APPLICATIONS OrganaBio is committed to providing reasonable accommodations to enable applicants with disabilities to have equal opportunity to search for a job opening or apply for a position. Any applicant requiring assistance with our career opportunities website or who needs accommodation due to a disability, should send an e-mail to [email protected]. This email address is not for general employment inquiries or correspondence. We may only respond to those requests that are related to the accessibility of the online application system due to a disability.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. OrganaBio is an E-Verify employer.

Salary

$72,000 - $82,000 per year