Sr. Engineer, Quality Control

Axogen•Vandalia, OH

4h•Onsite

About The Position

The Sr. Engineer, Quality Control is a self-motivated individual that can provide test method optimization and qualification support through implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and compliance to meet Biologics requirements, while introducing lean processes into the laboratory. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing, qualifications, and documentation.

Requirements

Bachelor’s degree in chemistry/biology, or closely related field
Minimum 5 years’ experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering preferably in a Biologics or Pharmaceutical related field.
Understanding of quality control instrumentation, troubleshooting, including data integrity and qualification
Leadership skills to support the analytical team (encompassing ELISA, pH, osmolality, KF, UV assay, eventually LC)
Problem solving using root cause methodologies including lean
Applying statistics and software in data analysis (example Minitab)
Quality system regulations and requirements (examples 21 CFR part 600, 21 CFR Part 1271, 21 CFR Part 210/211)
Six Sigma Green or Black Belt certified

Responsibilities

Partner with QC Lab Management on ongoing and new process improvements, efficiency improvements, and cross-training. This includes any validation addendums or improvements and optimization of systems.
Develop protocols for projects such as method improvements, oversee execution of the protocols, author final reports and manage approval and implementation.
Direct the completion of Qualification and Re-Qualification requirements for QC Lab Instrumentation and new equipment. Contribute to validation planning for new and existing processes, instrumentation, or methods.
Drive completion of OOS investigations, deviations, and change control for QC and work with QS to improve investigation module and reports related to all testing completed at APC or contract labs. Partner with Corporate Quality as required.
Confer with external and internal departments (example Operations, Corporate Quality, Engineering, Regulatory, Quality Assurance, Quality Systems) concerning various projects and actions required.
Lead and participate in BLA support including PAI action steps, audit actions, document/procedural updates, MOC creation/execution, CAPAs.
Define and implement automation and new capital projects to optimize QC Lab
Prepares reports and presentations by collecting, analyzing, and summarizing data, making
Provide statistical data support for various Lean projects within Develop any Project Charters required for Lab Improvement/cost savings projects.
Lead Quality Control issue resolution by applying root cause
Participate in FDA inspections and internal
Deploying proactive quality controls for consistent and predictable quality
Establish and track metrics for monitoring laboratory
Report to management on quality issues and
Provide functional support as needed for all team