Sr. Scientist, Quality Control

Axogen•Vandalia, OH

8h•Onsite

About The Position

The Quality Control Sr. Scientist provides test method and qualification support along with implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and process improvements to meet Biologics requirements. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing and documentation.

Requirements

Bachelor’s degree in chemistry/biology, or closely related field
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, and testing methods including data integrity and qualification requirements. Specific experience with ELISA based assays and software preferred.
Problem solving using root cause methodologies including lean principles.
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)

Nice To Haves

Six Sigma Green/Black Belt preferred

Responsibilities

Drive completion of OOS investigations and deviations 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.
Develop protocols for projects such as method improvements, oversee execution of the protocols, author final reports and manage approval and implementation.
Partner with QC Lab Management on ongoing and new process improvements, efficiency improvements, and cross-training. This includes any method validation addendums or improvements.
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.
Manage Commercial stability studies and coordination of sample testing and reports in partnership with QC Manager.
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 Operations. Ensures that required testing methods are in place for all testing required for Tissue and Biologics.
Prepares reports and presentations by collecting, analyzing, and summarizing data, making recommendations.
Provide statistical data support for various Lean projects within QC. Develop any Project Charters required for Lab Improvement/cost savings projects.
Lead Quality Control issue resolution by applying root cause methodologies.
Participate in FDA inspections and internal audits.
Deploying proactive quality controls for consistent and predictable quality outcomes.
Establish and track metrics for monitoring laboratory effectiveness.
Report to management on quality issues and investigations.
Provide functional support as needed for all team members.