Quality Compliance Specialist
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20089-AB1
Compensation : 90000.00 - 95000.00 USD/YEAR
Start Date : 01/08/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Biology or Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Quality Compliance Specialist responsible for QA Compliance activities supporting company Quality Systems and client procedures.
- Activities include documentation, running investigations, CAPAs, SOPs, qualification and validation reports, and collecting and analyzing QC data.
- Supports internal and external audits with Health Authorities and clients.
- Collaborate with Operations, Facilities, QC, and EH&S to provide guidance through all stages of the investigation / CAPA processes.
- Generate appropriate CAPAs to increase compliance and prevent repeat occurrences of deviations.
- Conduct trend analysis of compliance related metrics such as deviations and CAPAs.
- Develop and communicate investigation strategy to key stakeholders.
- Collect necessary information from appropriate department to close investigation and CAPA. Review and approve investigations and CAPAs.
- Conduct weekly status update meetings with cross functional departments.
- Monitor Deviation reporting and CAPA KPIs and provide detailed updates and information to management.
- Prepares and issues change control as necessary.
- Ensure adherence to all regulatory agency and company compliance regulations.
- Performs supplemental investigations and/or participates in project teams.
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 Investigation reports, CAPAs, SOPs, 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 in supporting health authority inspections and/or client audits preferred.
- Able to work occasional weekends, nights, and/or holidays as necessary.
Contact: Allan Berman
To search all of our 100+ jobs, please visit https://jobs.terkotech.com/
Please send all inquiries to Allan.Berman@TerkoTech.com