Sr. Specialist, Quality Control

Celularity•Florham Park, NJ

2d•Onsite

About The Position

The Sr. Specialist, Quality Control, is responsible for supporting routine product testing for clinical and commercial products, product visual inspection, retain/sample oversight, microbiological activities and assay management. This role must interface with multiple groups, independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will serve as QC SME during audits.

Requirements

Bachelor’s degree in a scientific discipline required.
Minimum of 5+ years of quality control and/or analytical experience in a cGMP-regulated environment.
Ability to understand, follow, interpret and apply good laboratory practices.
Strong organizational and time management skills
Ability to work well in a team environment
Dynamic individual with the ability to communicate and engage others
Independent and self-starting.
Eager and adaptable
Excellent verbal and written communication skills as well as strong focus and attention to detail.
Ability to don personal protective equipment (PPE) during various role responsibilities

Responsibilities

Perform routine testing of company’s cellular, tissue, in-process and final product samples according to approved methods, specifications and procedures.
Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
Accurately record testing activities and results in controlled documents and/or electronic systems.
Assist with assay and equipment troubleshooting, cleaning and maintenance.
Support clinical and commercial disposition activities by ensuring required testing and activities are complete within established timelines.
Generate product Certificates of Analysis and ensure completeness and accuracy.
Work with Quality team to facilitate readiness for product release.
Initiate or support investigations associated with deviations and OOS/OOT results.
Support equipment calibration and qualification activities.
Support execution of analytical method transfers.
Ensure proper training, qualification and implementation of transferred methods.
Coordinate and execute testing and inspection of incoming raw materials, components or supplies used in cGMP manufacturing.
Collect and prepare samples in accordance with approved sampling plans.
Manage retain, stability, in-process, raw material and finished product samples as needed.
Prepare samples for testing and shipment to external laboratories.
Review incoming test reports.
Maintain receipt and timely filing of testing results.
Perform routine and timely visual inspection of cellular, tissue and finished product evaluating compliance to defined quality attributes.
Execute routine environmental monitoring activities in support of cGMP manufacturing and quality control operations, as applicable.
Participate in internal audits, regulatory inspections and 3rd party audits.