QA Specialist Batch Record Reviewer

2 months ago

Florham Park, United States Celularity Full time
Job DescriptionJob DescriptionDescription:

Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.

The Quality Assurance (QA) Specialist reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Work with other departments to ensure the quality of products, review change controls, and support investigations of quality issues.

Requirements:

Required Competencies: Knowledge, Skills, and Abilities

· Familiarity with cGMP environment (i.e., ISO 5, ISO 7, and ISO 8).

· Ability to understand, follow, interpret, and apply good laboratory practices.

· Ability to assist with OOS (Out of Specification), OOT and CAPAs

· Analyze and trend data using instrumentation software and Excel.

· Problem solving ability/mentality, technically adept and logical.

· Ability to communicate effectively with peers, department management and cross- functional peers.


Duties and Responsibilities

· Conducts QA review of various product-related records for completeness and accuracy according to SOP (Standard Operating Procedures) (e.g., Clinical/Donor stock and production batch records, QC EM/Analytical data, donor eligibility).

· Conducts QA review of biobanking files for completeness and accuracy.

· Conducts QA oversight of documentation necessary for transplantation of materials.

· Ensures review and quality decision of all batch related documentation and performs the batch disposition.

· Conduct issuance of Batch records and labels.

· Follow-up to verify completion of quality event activities.

· Supports incoming materials inspections and release.

· Communicate and resolve errors or discrepancies with related personnel

· Conducts QA verification and reconciliation of product packaging and labeling.

· Conducts QA review and approval of various calibration, validation and environmental monitoring documents for accuracy and trends.

· Provides input/suggestions for revising and improving processes and procedures.

· Handles product related quality events such as change controls and investigations.

· Coordinates activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure.

· Coordinates activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure.

· Implementation and ensures adherence of appropriate Health Authority regulations and Celularity quality standards.

· Write, review, and approve Standard Operating Procedures (SOPs) and associated Work Procedures (WPs) and Forms (FRMs) Quality Risk Assessments (QRAs), Specifications, Batch Production Documents (BPDs), Manufacturing Production Documents (MPDs), or other documentation, as needed.

· Provide support for self-inspections and external audits.

· Interact with FDA, partner and /inspectors, as needed.

· Support regulatory filings.

· Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT) initiatives, high quality performance.

· Represent QA at corporate and site operational and cross-functional meetings, providing QA input and disseminating information back to QA as needed.

· Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.

· Perform or support any other tasks necessary to maintain the product quality and site compliance, as needed.

· Performs other QA duties as assigned.


Education and Experience

· Bachelor’s degree in a scientific discipline required.

· Minimum of 2 years of quality assurance experience

· Detail oriented with high degree of focus.

· Able to follow instructions and procedures, both written and verbal.

· Able to perform with minimal supervision and contribute to a team environment.

· Able to communicate results and issues effectively, both written and orally.

· Able to exercise judgment within defined procedures.

· Working knowledge and ability in using Microsoft Office.

· Knowledge/experience with electronic quality systems and enterprise resource planning systems preferred (e.g., ACE, TrackWise, GreatPlains, Salesforce).


Working Conditions

· The incumbent will be working in an office environment but will often visit and engage with manufacturing personnel in the laboratories.

· Flexible scheduling required.

· Some light lifting may be required occasionally.

· Should be able to gown aseptically.


This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities considered incidental or secondary to this job's overall purpose. Employees/contractors holding this position will be required to perform any other job-related duties as requested by management.


Must be authorized to work directly for Celularity in the U.S.


No agency submittals accepted


Celularity is an Equal Opportunity Employer

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