QA Specialist (Contract)

United States·Emeryvillemid

OtherQa Specialist

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Quick Summary

Key Responsibilities

Quality Assurance: 100% of time Equipment onboarding,

Requirements Summary

Education: Background in the Life Sciences preferred. Experience: 2+ years within the Biotech or similar industry.

Technical Tools

OtherQa Specialist

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY:

As a Quality Assurance Specialist (Contract), you will be required to perform Quality functions such as equipment onboarding and logbook, batch and calibration record review, management of Nonconformance investigations, CAPAs, Change Controls, Deviations and internal audits. Role will be 4 days onsite and 1 day remote.

RESPONSIBILITIES:

Quality Assurance: 100% of time

Equipment onboarding, logbook batch and calibration record review
Nonconformance investigation management
Deviations
CAPAs
Change Control
Internal audits
Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

Background in the Life Sciences preferred.

Experience:

2+ years within the Biotech or similar industry.

Skills:

An understanding of QA’s function in the manufacture of pharmaceuticals/biologics and the associated cGMP and regulatory standards is essential.
Certificate in Quality Assurance is a plus.
Excellent communication skills, both verbal and written.
Strong data collection and analysis skills.
Good attention to detail.
Physical Requirements of the Role: Primarily computer use and long periods of sitting, with some standing.

Hourly salary range: $49.00 - 59.00

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities