Position Title : Quality Assurance Specialist Duration : 6 Months Location : Bothell WA
Quality Systems support within Quality Operations. Ensure that the client products manufactured at external contract manufacturers are manufactured, tested and released according to established specifications and the principles as per Client directives.
Duties and Responsibilities: • Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and metrics. • Investigation & CAPA Review Board Administrator. Compile slides and assemble presentations, schedule logistics, meeting facilitation, and author meeting minutes. • QMS Deviation and CAPA phase tracking and due date monitoring. Ensure adherence to deviation and CAPA due dates and extension process. • Deviation Trending Program administrator. Perform quarterly analysis and identification of adverse trends. Author quarterly deviation trend report. Work cross-functionally to determine remedial actions to reduce recurrence and implement effective CAPAs. • Deviation Trend Review Board logistics, preparation, facilitation, and meeting minutes. • Perform routine and ad hoc queries of Quality Management System to support business operations. • Other duites as assigned by manager.
Experience /Knowledge Desired: • A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems. (Veeva experience preferred) • Advanced Excel knowledge and proficiency. Pivot table and reporting proficiency. • Advance Smartsheet Dashboard Creation • Technical report authoring experience. e.g. Deviation Trend Report • Must exercise accurate judgment and be able to evaluate information critically and decide upon the appropriate course of action. • Must be able to correlate events and determine the action plan required to avoid recurrence. • Excellent verbal and written communication skills are essential. • Excellent interpersonal skills at every level. • Capable of managing priorities and timelines.
Education: B.S. in any Science.
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: $82.00/hr.
