QA Specialist (Contract)
4D Molecular Therapeutics · Emeryville, California, United States · $102K–$123K/yr
Biotechnology Research · 51-200 employees
About the role
The QA Specialist will perform quality functions including equipment onboarding, logbook and record reviews, and management of nonconformance investigations. They are also responsible for handling CAPAs, change controls, deviations, and conducting internal audits.
What they look for
Requirements
Candidates should have a background in Life Sciences and at least 2 years of experience in the biotech or similar industry. A strong understanding of QA functions in pharmaceutical manufacturing and cGMP regulatory standards is essential.
Full description
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
