Quality Assurance Coordinator
Remote, Monday through Friday, 10-20 hours a week (flexible)
Temporary, Part-time assignment ending on 12/31/25

About Sanguine:
Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.

About the Role:
The Quality Assurance Coordinator supports routine quality system activities with emphasis on reduction of cases/complaints and deviations, review and sign-off of Certificates of Analysis (CofA) in accordance with assigned authority, population of Leadership/QA monthly meeting metrics and issuance of meeting minutes, document control and SOP lifecycle administration (processing and periodic review), vendor/supplier review and approvals, and maintenance of training files and onboarding activities. This role can function as a quality control and/or quality assurance position, and reports to the Vice President, Quality and Compliance.

Primary Responsibilities:

Cases, Complaints, and Deviations:
- Log and route new cases/complaints and deviations; ensure records are complete and accurate.
- Monitor due dates, follow up with owners, and escalate at-risk items to prevent lateness.
- Trend and summarize data for monthly reporting; identify recurrence and propose targeted corrective actions to support reduction.
- Maintain trackers and dashboards used for Leadership/QA monthly review.

Vendor/Supplier Review and Approvals:
- Maintain the Approved Supplier List and supplier files, including questionnaires, certifications, quality agreements, and audit records.
- Coordinate supplier qualification and re-qualification packets; route for review and approval.
- Track expirations and obtain timely renewals from suppliers.

Leadership/QA Monthly Meeting Support:
- Populate agendas and quality metrics (complaints, deviations, CAPA status, training completion, SOP currency, supplier status, etc.).
- Record and issue meeting minutes; log and track action items to closure.

SOP Processing and Periodic Review:
- Format, route, and control SOPs, work instructions, and forms through draft, review, and approval.
- Maintain the Master Document List; schedule and track periodic reviews to ensure document currency.
- Upon approval, execute release, and update associated training assignments.

Training Files and Onboarding:
- Create and assign curricula in the training system; maintain individual training files and completion reports.
- Coordinate new-hire onboarding checklists; ensure required GxP training is completed prior to independent work.
- Issue reminders and report overdue items to management.

General QA Support:
- Perform data entry and housekeeping in eQMS/LMS; maintain controlled logs and forms.
- Support audit/inspection readiness activities, including file retrieval and index maintenance.

Position Requirements:
- Associate’s or Bachelor’s degree in Life Sciences or related discipline preferred.
- 0–2 years of experience in Quality Assurance or regulated life-sciences environment (GxP/ISO) preferred; training provided.
- Ability to read and follow SOPs; strong attention to detail and documentation accuracy.
- Proficiency with spreadsheets and documents (Excel/Google Workspace).
- Clear written and verbal communication; effective organization and time management.
- Familiarity with FDA/ISO concepts (e.g., 21 CFR, ISO 9001) is a plus.

Working Schedule:
Monday through Friday, 10-20 hours a week (flexible)
Temporary, Part-time assignment ending on 12/31/25

Pay:
$20/hour

Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.

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