Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20090-AB1
Compensation : 90000.00 - 95000.00 USD/YEAR
Start Date : 01/09/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Biology or Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a QA Specialist for Client Services responsible for client specific QA activities including document management, issuance, investigation, CAPA, creating and updating SOPs, Qualification and Validation Reports, etc.
- Serve as company client services representative at project kick off and weekly meetings.
- Work with various departments to ensure project related activity is completed on time
- Create, update, and approve client project documents including SOPs, Batch release templates, label templates, batch records, change controls, etc.
- Participates in tech transfer activity to ensure adherence to quality system standards.
- Proactively identifies risk and prepares mitigation strategies associated with project and client work.
- Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.
- Monitor project deliverable quality activities of internal team members.
- Draft initial Quality agreement and complete necessary revisions based on client and company requirements.
- Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate.
- Provide quality data to Project Manager to create KPI metrics.
- Build rapport with clients by resolving their concerns with internal team. Provide appropriate responses to client requests or concerns.
- Update and maintain accurate client project-related documentation using (i.e., SharePoint).
- Train Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline.
- Support and participate in internal, regulatory agency and client audit requests.
- Identifies and supports continuous improvement opportunities throughout various company departments to enhance operations.
Required Qualifications :
- BS in Biology, Chemistry, or other similar scientific field of study.
- At least 5 years experience in QA in the pharma/life sciences industry with experience in aseptic manufacturing of biologics.
- Experience in authoring and approving CAPAs, SOPs, Deviation reports, Investigation reports, and other documentation in a cGMP/cGTP environment.
- Knowledge of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
- Familiar with FDA, ISO, and other regulatory agency guidelines.
- Understanding of GMP, GDP, and GLP.
- Experience in both clinical and commercial manufacturing is preferred.
- Experience participating health authority inspections and/or client audits preferred.
- Able to work occasional weekends, nights, and/or holidays as necessary.
Contact: Allan Berman