Senior Quality Assurance Representative

Merck•Indianapolis, IN

2d•Onsite

About The Position

This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility. Responsibilities include but are not limited to: Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed. Performs and documents line clearances and room release for manufacturing use. Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented. Monitors the formulation and filling processes to ensure cGMP compliance. Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators. Requires qualification in aseptic gowning and certification as an aseptic processing SME. Observers, reports, and documents operator cleaning and disinfection practices. Documents, reports, and trends observations stemming from Quality Oversight. Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices.

Requirements

Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience.
OR High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience.
Requires qualification in aseptic gowning and certification as an aseptic processing SME.

Nice To Haves

Experience with computer software applications including Microsoft Excel, Word, and Access.
Experience with Quality Management computer systems and SAP.
Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning.

Responsibilities

Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed.
Performs and documents line clearances and room release for manufacturing use.
Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented.
Monitors the formulation and filling processes to ensure cGMP compliance.
Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators.
Observers, reports, and documents operator cleaning and disinfection practices.
Documents, reports, and trends observations stemming from Quality Oversight.
Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices.