Senior Quality Assurance Specialist
East Windsor NJ
: 8-5 pm 1st shift
Minimum of a BSc in Chemical or other relevant Engineering area or Chemistry/Science,
Minimum of 5 years of industrial operational experience working under cGMPs,
Brings 3 years of working in Quality Assurance
Understanding of the cGMP requirements and knowledge of Quality by Design principles.
Hands-on experience in writing and reviewing documentation for process, operations and validation.
Competent in the application of cGMP principles to process, equipment, and facility.
Good coordination and communication skills (written and verbal).
Results driven, team player, able to deal with multiple projects/tasks.
Available, autonomous and able to take ownership.
The Senior Quality Assurance Specialist promotes high quality standards and a continuous improvement culture within the operational areas at the New Jersey site in order to ensure that these are aligned with applicable quality regulations and the company’s high quality standards. This role provides guidance and support to the project team in Quality Assurance (QA) related activities, assists the Head of Quality in achieving the department objectives through planning and management of other more junior QA Specialists, and manages the cGMP programs (e.g. validation, qualification, stability, environmental control). This role will be responsible to provide training, mentorship and coaching to more junior QA Specialists to attain the goals and responsibility of the Department.
Assure documentation control on Site.
Prepare SOPs, department IOPs, quality related reports and change control documents (PdAs), when appropriate.
Approve IOPs of the various areas.
Approve process master documentation.
Approve product specifications and associated documentation.
Release final product.
Review completed batch records and associated deviations.
Periodically follow-up of ongoing deviations and PdAs to assure timely closure of documentation (recommended weekly follow -ups)
Approve quality related and/or project specific protocols.
Responsible for evaluation/approval of equipment cleaning.
Approve equipment qualification protocols and reports.
Approve process validation protocols and reports.
Manage site stability program including approval of stability data report.
Handle the client's quality related issues.
Provide support during Client audits / Inspections.
Periodic follow-up of client audits action plans and client (or self) complaints.
Actively communicate with the various areas to identify areas for improvement.
Conduct regular inspections of the operational areas to verify compliance with cGMPs (i.e. Internal Audits).
Provide training to staff in cGMPs.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.