Senior Specialist, External Quality Operations

Job not on LinkedIn

🔥 9 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $80k - $129k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 0%

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Mallinckrodt Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1867

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Mallinckrodt Pharmaceuticals is a global biopharmaceutical company that specializes in developing and delivering innovative therapies for patients with complex conditions. The company is committed to addressing unmet medical needs and improving patient care through its range of pharmaceutical products, including treatments for pain management, autoimmune disorders, and more.

📋 Description

• Support externally manufactured pharmaceutical and biopharmaceutical products • Build, maintain and manage relationships with CMO counterparts and cross-functional team members • Review and approve CMO batch-production documentation • Review batch records, address discrepancies and escalate issues to management • Prepare disposition and release certification for reviewed batch records • Manage CMO governance and oversee third-party manufacturing, packaging and testing activities • Communicate with CMOs to support timely manufacture and resolve quality issues • Monitor product and CMO performance • Manage quality records, including deviations, change controls and CAPAs • Monitor cold-chain transportation qualification and routine operations • Provide input into Technical Quality Agreements • Support post-launch quality activities in various countries • Manage delegated projects • Review and approve stability program protocols • Review and manage data • Drive audit readiness and compliance • Champion continuous improvement projects at CMOs and within Keenova

🎯 Requirements

• Bachelor’s Degree in scientific discipline, preferred • 5–7 years’ experience working as a Quality Specialist • Direct experience working with Quality Systems, including deviations, change controls, training, supplier qualification and document management systems • Knowledge of cGMP requirements for pharmaceutical manufacturing • Knowledge of GDP and ISO 13485 • Ability to work in a remote, office-type environment • Limited travel as needed

🏖️ Benefits

• Competitive pay and benefits • Bonus eligibility in accordance with the applicable program • Remote work arrangement • Limited travel as needed