INCOG BioPharma Services Careers - QC Stability Coordinator

INCOG BioPharma•Fishers, IN

48d•Onsite

About The Position

The Stability Coordinator plays a pivotal role in ensuring the integrity, consistency, and reliability of products throughout their lifecycle. This position is responsible for managing stability studies, maintaining compliance with regulatory standards, and supporting cross-functional teams to uphold product quality. The ideal candidate demonstrates strong organizational skills, attention to detail, and the ability to coordinate multiple projects simultaneously.

Requirements

Bachelor's degree in Biology, Chemistry, or a related field.
Minimum of 3 years in a regulated laboratory, of which at least 2 years have been in a role of hands-on experience with Quality Control.
Project management and awareness of scheduling tools.
Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, SharePoint, PowerBI, etc.).

Responsibilities

Design, schedule, and oversee stability protocols for new and existing studies.
Coordinate Stability timepoint pulls and communicate associated testing with QC laboratories.
Ensure studies are conducted in accordance with regulatory guidelines and internal procedures.
Assign Stability Study Summary Reports and track to completion within the required timeframe.
Maintain timely and accurate inventory.
Draft Stability initiation documentation, and support laboratory testing by delivering associated documents.
Collect, organize, and analyze stability associated data to identify trends, potential issues in stability reporting, and report the health of the stability program.
Communicate study progress, results, and action items to stakeholders.
Provide Laboratory information and documentation requests to site management and customers required for regulatory filings and product import/export needs, when required.
Support assessment of method reliability and trend data for inclusion in PQR/APR.
Liaise with Quality Assurance, Project Management, and Supply Chain to coordinate stability-related activities.
Liaise with Validation/Facilities about equipment maintenance, calibration, requalification, and impact assessments for excursions
Participate in and adequately represent the QC laboratories in customer and regulatory audits of the facility.
As a part of the employee's job requirements, the employee may be required to handle waste including hazardous waste. The employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.