What are the responsibilities and job description for the Senior Quality Engineer position at Hubot | Tri Pac, Inc. CDMO?
About Hubot
Hubot, Inc. is an FDA-registered contract development and manufacturing organization (CDMO) serving global pharmaceutical and personal care brands — including Fortune 500 clients. With 25–30% projected year-over-year growth through 2030, we're building the infrastructure, systems, and team to match world-class ambition.
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This position is not eligible for visa sponsorship.
The Opportunity :
The Senior Quality Engineer combines GMP expertise with a systems mindset supporting daily quality operations, leading investigations, and playing a hands-on role in our eQMS upgrade, maintenance, and administration.
What You'll Do
- Lead failure investigations using root cause analysis tools (5-Why, Fishbone, FMEA) and drive CAPA implementation
- Review Batch Records, SOPs, and change controls for GDP compliance and regulatory alignment
- Evaluate proposed process and design changes for change control requirements, guide qualification and validation criteria
- Monitor and implement procedures related to Quarantine, Hold, Expired, Damaged, Return Goods, and Recalled product
- Provide routine analysis of KPIs and quality performance indicators; identify trends
- Support risk management file updates for process changes; implement process controls and error-proofing measures
- Collaborate with functional process owners to train, mentor, and facilitate QMS requirements and continuous improvement
- Support and administer eQMS modules CAPA, document control, deviation management, audit management, and training records
- Contribute to eQMS upgrade, validation, and ongoing maintenance; support process, equipment, and method validation activities as required; ensure 21 CFR Part 11 compliance and audit trail integrity
- Support internal audit programs and assist in preparation for FDA, ISO, and customer audits
What You Bring
- 7-9 years in a GMP-regulated environment pharma, personal care, or chemical manufacturing
- Working knowledge of FDA 21 CFR 210/211, ISO 9001, ISO 22716, and 21 CFR Part 11
- Hands-on experience with eQMS platforms (Veeva Vault, MasterControl, TrackWise, or similar)
- Strong written English and ability to collaborate effectively across time zones
- BA/BS in Engineering, Quality, Life Sciences, or related field
How We Measure Success
- ✅ CAPA closure rate on time ≥ 95%
- ✅ GDP adherence on batch record and SOP reviews ≥ 98%
- ✅ eQMS module uptime and audit trail integrity 100%
- ✅ Internal audit findings closed within defined timelines ≥ 90%
- ✅ At least one eQMS process improvement or automation implemented By Month 9
What We Offer
- Competitive base salary commensurate with experience
- Medical, dental, and vision insurance
- 401(k) with company contribution
- Paid time off and holidays
- Short- and long-term disability coverage
- Professional development and certification support
Apply Today
Join a team where safety isn't a checkbox — it's a competitive advantage.
🌐 www.hubot.us
Hubot, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.