Top Skills: • A minimum of 5 years of relevant Quality experience in a GMP/FDA-regulated environment. • Understanding of Quality Risk Management principles and application within the quality systems
This role is part of the site’s Quality Systems team and will primarily focus on maintaining the Quality risk management program at the Bothell manufacturing facility. The program is intended to promote the self-identification of risk areas and implementation of risk mitigation measures for operations, cGMP compliance, and business continuity. Additionally, this role supports the use of various risk management tools to lead complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.
• Contribute to the writing, coordination, review, and maintenance of the Bothell Risk Management Standard Operating Procedures (SOPs) and associated documents. • Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with the Quality System • Facilitate planning, execution, and completion of risk assessments by guiding cross-functional team members • Conduct risk reviews and escalate findings, as appropriate, to QRM team • Track the status of risk mitigation actions through to completion • Track the implementation of corrective actions associated with risk assessments and verify the actions are aligned with the source event • Responsible for maintaining the Bothell Quality Risk Catalog/Registry • Support the creation, revision, and approval of Quality Risk Management Reports • Proactively deploy methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve the effectiveness of the Risk Management program. • Collaborate to improve Quality Risk Methodologies and practices • Generate data for Quality Risk Management Performance Metrics
Knowledge and Skills Required: • A minimum of 5 years of relevant Quality experience in a GMP/FDA-regulated environment. • Understanding of Quality Risk Management principles and application within the quality systems • Strong technical writing skill set and ability to critically review reports while effectively expressing Quality principles. • Quality and continuous improvement • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships. • Strong project planning skills. • Strong knowledge of cGMPs and Health Authority requirements • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems) • Strong experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices • Proven experience working as a detailed oriented team player with effective planning, organization, and execution skills • Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc). • Strong computer skills with MS Office (e.g. Word, Visio, and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System). • Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
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.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $62.58/hr.
