*Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: - 3-5 years of GMP work experience - Familiarity with Batch Records - Deviations Experience Preferred - Associates or BA Degree preferred, or HS Diploma + relevant work experience - Soft skills include- strong cross-functional experience, strong interpersonal skills
*Job Description: The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant. Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports the client’s release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at client's with an emphasis on supporting Manufacturing with a Quality on-the-floor presence within a regulated cGMP environment.
The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at Jump by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.
The QA Specialist primary role is on-the-floor and contributes with off-the-floor projects and activities that are just as significant as on-the-floor work.
*Education: Bachelor’s degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required. • 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. • Hands-on experience with batch record review and product disposition is preferred. • Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation. • Strong computer skills with Word and Excel and other electronic manufacturing systems. • Detail oriented team player with effective planning, organization, time management and execution skills. • Proven experience working on teams where combined contribution, collaboration, and results were expected. • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. • Ability to work in a high paced team environment. • Strong written and verbal skills.
*ROLES AND RESPONSIBILITIES: • Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors. • Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP. • Provides technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities. • Review deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs). • Own, review, and approve deviations, including Deviation classification and completion of Impact Assessments, as applicable. • Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations. • Oversee manufacturing operations from patient material receipt to drug product pack out. • May support internal and external audits, including documenting observations. • Own and participate in review and approval for CAPAs. • Identify and facilitate continuous improvement projects. • Revise Standard operating Procedures as needed, and review/approve document revisions. • Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers. • Provide training, coaching, and feedback for GMP guidance. • Continue support of continuous improvement culture and operational excellence methodologies. • Support change control initiatives as applicable.
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.
