Advanced knowledge of end-to-end PV procedural requirements
Ability to review/direct PV procedural documents to ensure compliance with international standards and regulations while also promoting a lean and efficient procedural framework.
Mid-level understanding of quality management, change control, and quality management systems.
Ability to learn and work in ETQ.
Advanced ability to work within fixed timelines and manage a high volume of work/multiple projects at one time.
Responsibilities:
Advise Global PV teams on change control of procedural documents before work is started to draft revisions.
Review change control documents to ensure Global PV business process owners are considering proper training as a part of the procedural changes.
Review and approve procedural documents in ETQ to ensure they meet the needs to ensure quality and compliance and strategically move towards a more lean and efficient procedural document framework governing pharmacovigilance and safety surveillance .
Comments/Special Instructions Anyone with experience using ETQ (a quality management system) would be preferred.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.
