QA lead technical operations
Summit, New Jersey
Experience: 0
Category: Scientific & Clinical
Brand: Joule
Job ID: 297975
Date Posted: 03/21/2023
Shortcut: http://jobs.systemoneservices.com/UCZkzs
Title: QA lead technical operations - QA lead technical operations
Location: Summit, NJ
Duration: 12 months
Start date: ASAP
Our client is looking for the following:
Responsibilities:
- 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.
With the following credentials:
Requirements:
- 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.
System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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