Senior Specialist, External Quality Operations

Mallinckrodt Pharmaceuticals•Malvern, PA

4d•$80,000 - $129,000•Remote

About The Position

The Senior Specialist, External Quality Operations supports externally manufactured products for Keenova with a product portfolio that includes pharmaceutical and biopharmaceutical products. The position is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional team members. The position is responsible for appropriate escalation to Manager/Director level management and above.

Requirements

Bachelor’s Degree in scientific discipline
Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
+5-7years’ experience working as a Quality Specialist.

Nice To Haves

Knowledge of cGMP requirements for pharmaceutical manufacturing
Knowledge of GDP and ISO 13485

Responsibilities

Preparation, review and approval of CMO documentation for batch production
Review of batch records, addressing discrepancies and escalating where required to management.
Preparation of disposition and release certification for reviewed batch records.
Management and oversight of third-party supplier activities relating to the manufacture, packaging and testing of product.
Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
Continuous monitoring of product and performance from CMOs.
Quality record management; deviations, change controls, CAPAs
Monitoring cold-chain transportation, for both qualification and routine
Input into Technical Quality Agreements
Post-launch support for quality activities in various countries, as needed
Management of delegated projects
Protocol review and approval
Data review and management
Drive the audit readiness program to always ensure audit compliance
As required.
Champion continuous improvement efforts for projects identified at the CMOs or within Keenova