Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)

Rentschler Biopharma•Milford, MA

10d•Onsite

About The Position

The Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods, stability protocols, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). They work independently with minimal supervision ensuring stability tests are performed promptly within predefined testing windows. The Quality Control Analyst II, Release and Stability Testing, ensures all work performed strictly adheres to cGMP, SOPs, and protocols. They collaborate with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals. They are responsible for identifying and resolving problems of diverse scope in which analysis of data requires evaluation of identifiable factors based on biochemical knowledge and background. Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Requirements

Bachelor's Degree in Life Sciences discipline
Minimum 3+ years’ experience in a cGMP analytical lab environment
Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently
Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
Able to use and learn standard office equipment and technology with proficiency

Nice To Haves

Experience in Empower chromatography software

Responsibilities

Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents
Create/revise SOPs, Protocols and Reports
Practice safe work habits and adhere to safety procedures and guidelines
Perform maintenance and cleaning of laboratory equipment
SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances
Update and track metrics for trending and reporting; stability and QC analytical data
Assists in training of new hires and retraining of QC laboratory staff, as needed
Performs other duties as assigned