Principal Quality Assurance Specialist – External Manufacturing

Job not on LinkedIn

🕒 July 16

🇺🇸 United States – Remote

💵 $150k - $190k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 27%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Loyal

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

📋 Description

• Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase • Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development • Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations • Review and approve validation protocols, raw data, and reports for test methods, processes, cleaning, and related activities • Manage the batch release program by reviewing executed documentation, raw data, quality events, and product disposition decisions • Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents for drug substance and final drug product release • Lead or support quality event resolution investigations, including OOS/OOT results and deviations, root cause analysis, CAPA development, and timely closure • Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review, Field Alert Reports, product withdrawal, and product recall processes • Perform data integrity and compliance assessments, including review against source documentation for regulatory submissions • Maintain communication with CDMOs and CTLs to achieve Quality objectives according to project timelines • Maintain awareness of evolving veterinary pharmaceutical regulations and update compliance strategies accordingly • Collaborate with Technical Operations, Analytical Development/Quality Control, and CMC Regulatory Affairs

🎯 Requirements

• B.S./M.S. degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field) • Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles • Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products • In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems • Experience managing CDMOs and collaborating effectively across cross-functional teams • Capable of working successfully in a team/matrix environment and independently, as required • Ability to meet deadlines, use time efficiently and effectively, and handle multiple assignments simultaneously • Ability to convey written and verbal information effectively and efficiently • Demonstrated ability to follow procedures and perform assignments accurately with careful attention to detail • Willingness to travel (10%) • Strong technical judgment and problem-solving • Attention to detail and commitment to quality • Excellent written and verbal communication • Ability to influence cross-functional teams and external partners • Effective project and time management • Collaborative mindset with a continuous improvement focus

🏖️ Benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member • Competitive salary • Company equity options grant for new hires