In-Process Quality Eng II

Endo•Saint Louis, MO

About The Position

The In-Process Quality Engineer II– Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies.

Requirements

BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.
Minimum of 1 year related experience in Quality stability programs.
Proven project management history.
Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements.

Nice To Haves

Excellent communication skills.
Ability to work in and promote a team environment.
Understanding and application of principles, concepts, practices, and standards within discipline.
Knowledge of stability chambers and laboratory equipment.
Ability to read and interpret graphs.
Ability to lead and influence people.
Understanding of basic statistical principles.
Understanding of analytical chemistry and OOS investigations.
Knowledge of US and international pharmaceutical manufacturing regulations/guidance documents
Knowledge of ELN, LIMS, Excel, MiniTab.

Responsibilities

Responsible for ensuring required stability testing is performed as per procedures, and ensures timely data review for multiple sites
Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations
Pulls and delivers stability samples at testing intervals
Package stability samples per study requirements for multiple sites
Maintains controlled substance inventory in compliance with applicable DEA regulations
Performs annual physical inventory of controlled substances
Works with LIMS team to ensure stability module of LIMS system is maintained and functional
Manages controlled and non-hazardous destruction inventory
Evaluates analytical data and stability documentation for accuracy and completeness
Provides statistical analysis of stability data
Responsible for packaging, labeling, and storage of stability samples for multiple sites
Creates stability study plans for all stability studies
Create and review stability impact revision protocols
Provide Stability support for sister sites
Train new hires into the department as needed for OJT per the stability training curriculum
Create product stability reports as requested
Receives/approves bulk stability samples in the Biovia and ELN systems.
Support the expansion of the stability program into the Zone IVB market.
Shares responsibility for Stability Packaging functions and sample pulls as needed.
Reviews and approves stability data sheets
Fulfills regulatory stability requests