QA Lead Technical Operations

Company: Axelon Services Corporation
Location: Summit
Posted on: March 19, 2023

Job Description:

Job Description:

Responsibilities:
This position is responsible for providing support for Product Quality Complaint (PQC) investigations, Change Control, and other Quality Systems. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with a number of Quality Systems. This position will facilitate and provide administrative support for meetings related to root cause analysis sessions with site SME s, Community of Practices/Network, Quality Systems team/department.

Primary responsibilities include:
Author, review, and approves Product Quality Compliant (PQC) investigations.
Ensure proper intake, initiation, evaluation, and investigation of PQC(s), provides input to functional groups during evaluation, investigation, closure and implementation of associated CAPA's
Contributes to the development and continuous improvement of the PQC process across the Cell Therapy Operations
Collaborate with cross functional teams (i.e. Scheduling & Cell Logistics , Global Drug Safety, manufacturing sites, etc.) to ensure proper communication and collaboration for PQC(s).
Support and train cross functional groups with guidance on PQC process to ensure accurate reporting, investigation, root cause analysis and corrective actions.
Perform routine and ad hoc Quality Systems metric reporting and analysis for the PQC(s) data.
Prepare metrics and perform periodic trend analysis for PQC(s) in support of CTDO management review.
Provide communication as to the status of PQC(s) deliverables to management, and stakeholders.
Act as PQC Subject Matter Expert (SME) to support cross functional groups for PQC(s) intake, investigations, approval, and reporting.
Support internal, external audits and regulatory inspections such as data gathering, PQC process support and/or other audit support functions as necessary.
Support corporate requests for compliance and regulatory assessments.
Support other Quality System administration as required.

Qualifications:
2+ year s relevant industry experience in a cGMP/FDA regulated environment, preferably 2 years Quality experience with one or more years of experience within Quality Systems.

" Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred.
" Knowledge of US and EU cGMP regulations and guidance.
" Past experience where one was required to work in a team based environment with a diverse group of people.
" Excellent writing and oral communication skills are required.

Keywords: Axelon Services Corporation, New York , QA Lead Technical Operations, IT / Software / Systems , Summit, New York