Title: Quality- QA Associate Location: Bothell, WA, 98011 This is an Onsite role Work Schedule: Wednesday - Saturday, 6AM - 4:30PM PST Duration: 12 Months
Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.
1. Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs. 2. Inspects and releases intermediates or packaged drug product per specifications. 3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications. 4. Drafts and reviews specifications and SOPs. 5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data. 6. May provide guidance to less experienced staff. 7. Provides sitewide support during daily walkthroughs of GMP areas.
Requirements:
• B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred. • 2+ years of relevant experience in a regulated environment with at least 2 years focused on product quality. • Knowledge of biotech product manufacturing. • Knowledge of US and EU cGMP regulations and guidance. • Knowledge of Oracle, BMRAM, MES, Veeva Infinity are a plus
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: $33.00/hr.
