Sr. Specialist, Quality Control

Regulatory Jobs; Florham Park (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Celularity Inc. is seeking a Sr. Specialist, Quality Control to support routine product testing, visual inspection and retention/sample oversight for clinical and commercial products.

The role interfaces with multiple groups, performs tasks independently, interprets results and supports audits as a QC SME when needed. Responsibilities include testing, documentation, troubleshooting, disposition support, CoA generation, OOS/OOT investigations, equipment qualification, sampling, and participation

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum of 5+ years of quality control/analytical experience in a cGMP-regulated environment.
• Ability to understand, follow, interpret and apply good laboratory practices.
• Strong organizational and time management skills.
• Independent and team-player with excellent communication and attention to detail.

Responsibilities

• Perform routine testing of cellular, tissue, in-process and final product samples per approved methods.
• Record testing activities and results in controlled documents or electronic systems.
• Assist with assay and equipment troubleshooting, cleaning and maintenance.
• Support disposition activities ensuring testing is completed on time.
• Generate and review Certificates of Analysis for product release readiness.
• Initiate investigations for deviations and OOS/OOT results.
• Support equipment calibration and qualification activities.
• Assist with analytical method transfers and training/qualification.
• Coordinate testing and inspection of incoming raw materials and components.
• Collect, prepare and ship samples to external labs; file results timely.
• Perform visual inspection of cellular/tissue products for quality attributes.
• Support environmental monitoring in cGMP manufacturing.
• Participate in internal audits, regulatory inspections and 3rd party audits.

Skills

Quality control

Analytical testing

cGMP

Documentation

Audits

Education

Bachelor’s degree in a scientific discipline

Job description

Description

About Celularity

Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease.

Purpose

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.

Role & 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.

Requirements

Minimum Qualifications (Must have)

• 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

Celularity Inc. is an equal opportunity employer

***THIS ROLE DOES NOT PROVIDE RELOCATION