Day to Day:
The Senior Quality Control Analyst will be joining the Quality Control team at a well-known Biotechnology company in the Greater Seattle area. The Senior Quality Control Analyst will be responsible for the organization of the laboratory, assigning assay to analysts, creating sampling schedules, and ensuring proper steps are followed from a batch's beginning to release phase. They also will be trained on all testing to support the lab, and will help in performing sample testing for raw material release testing. This candidate will help in assisting the manager in the laboratory's day-to-day activities and will be helping with managing routine meetings, analyzing and compiling data for reports, and identifying/leading continuous improvement projects.
Applying the principles of good manufacturing practices (GMP) on a daily basis
Performing sample testing for raw material release testing
Analyzing and compiling data and preparation of reports
Reviewing assays/data for compliance to specifications and reports abnormalities
May require lifting/moving heavy objects.
Supporting/managing the daily activities of the lab (responding to RUSH requests, starting raw material batches, assigning of assays)
Support Release of raw material lots, CoA generation and approval
Creating and revising standard operating procedures (SOP's, Specifications, and Test Methods) and other documents as needed
Identifying and leading continuous improvement projects
Supporting special projects for analytical problem solving
Participating in the qualification and validation of test methods
Troubleshooting laboratory or system anomalies
Authoring and owning deviations, CAPAs and Change Controls
Method or system development and/or optimization.
Training other personnel
Serving as SME for Test Methods or other areas of expertise
Providing oversight for programs, specific to job function
Representing QC in cross-functional teams
Weekend, Holiday, overtime, and off-hour work may be required as needed to support manufacturing.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/ .
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.