Quality Specialist

Job not on LinkedIn

🕒 Yesterday

🇺🇸 United States – Remote

💵 $55k - $75k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

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MSBiotec®

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🌾 Agriculture

🧬 Biotechnology

💰 Private Equity Round on 2018-10

Agriculture • Biotechnology

MSBiotec is not described in the supplied text; the available material appears to be for Axiota Animal Health, a company that develops prevention-focused, science-backed products for beef and dairy cattle such as Lactipro (a rumen-native probiotic delivering a proprietary lactic acid utilizer) and Multimin 90 (an FDA-approved injectable trace mineral supplement). The text emphasizes supporting cattle health, productivity, and resilience across operations (cow/calf, stocker, feedlot, dairy) and references Technology Centers for research and proprietary processes.

📋 Description

• Manage quality and compliance responsibilities for a globally registered sterile injectable veterinary drug product • Oversee document control within the quality management system • Prepare documents and revisions for review and editing • Prepare key data for quality metrics and assessments • Assist with related reports, summaries, and evaluations • Collaborate with cross-functional teams on FDA submissions of marketing and technical material through the FDA electronic portal • Investigate incoming complaints, defects, deviations, and OOS according to internal procedures • Assist with Quality Agreement contract drafting and review • Support quality risk assessments and external audits • Collaborate with external business partners to ensure compliance with internal standards and external regulatory requirements • Support other GXP functions as required • Collaborate with assigned CMOs, vendors, and distributors • Report to the Global Director of Quality and Regulatory for the Multimin Product Line

🎯 Requirements

• This position is not eligible for visa sponsorship • Minimum of 2 years of pharmaceutical industry experience • Minimum of 1 year in a Quality or regulatory role • Experience in the Animal Health industry preferred • Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or a related field • Agile, proactive mindset toward Quality and cGMP compliance • Ability to assure suitability and cGMP compliance of the Supplier Quality program • Excellent communication and presentation skills • Ability to articulate complex information to stakeholders and partners, including regulators and customers • Experience with MS Office software suite • Experience with complex projects • Ability to keep pace and meet deadlines with good organization and planning skills • Currently live in or be willing to self-relocate to the Central or Eastern time zone • Comprehensive knowledge of global cGMP regulatory requirements for veterinary medicine and sterile injectable manufacturing processes preferred • Ability to work in a multi-disciplinary setting and facilitate strategic goals preferred • Background in continuous improvement and implementation of quality metrics preferred • Strong interpersonal and communication skills in diverse settings preferred

🏖️ Benefits

• Bonus • Medical insurance • Dental insurance • Vision insurance • Life insurance • 401K retirement plan with match • FSA • HSA • EAP • Short-term disability • Long-term disability • Paid time off • Paid holidays • Occasional travel

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