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Full-timeDescription
SUMMARY
The Quality Control Associate I, is responsible for supporting the control and management of samples within QC and performing routine testing of in-process, release, and stability samples following written methods and procedures. The position will work as part of the Analytical Development (AD) / Quality Control (QC) group to support the team responsibilities. Adherence to GMP/ GDP guidelines and ability to follow SOP’s is required.
JOB RESPONSIBILITIES
Essential Functions? Perform routine QC responsibilities as assigned by supervisor including:? Supporting control and management of samples by receiving, aliquoting, and processing samples within QC.? Conducting routine and non-routine analyses of GMP product and raw material as assigned using appropriate analytical methods.? Performing peer review of test results.? Initiate and assist in the closure of Quality events (Incident Reports, Deviations, OOS’s, OOT’s etc.)? Support AD/QC lab management and administrative tasks.? Compile data for documentation of test procedures and preparation of reports.? Apply acceptable cGMP practices during execution of all work tasks.? Regularly update management on status of testing and projects.
Seek additional guidance as needed.Supplemental Responsibilities? Additional QC responsibilities including laboratory and equipment maintenance, QC document management, QC inventory control, contract lab coordination, and reconciliation of sample requests/documents as needed? Assist in Analytical Development tasks and projects as assigned.? Assist in assay development, transfers, validation of analytical methods, and testing product GMP samples as assigned.? Assist in improving QC systems as assigned by supervisor, including revising system or analytical method SOPs.RequirementsEducation and Experience.? BS or advanced degree in chemistry, biology, biochemistry or related life sciences discipline.
experience is not required, OR? High School Diploma/GED with 3 or more years of experience in Quality Control within GMP biopharmaceutical or biotechnology industry.? For HS/GED, experience with sampling and testing in a GMP manufacturing facility? Adherence to GMP/ GDP guidelines and ability to follow SOP’s is required.? Experience with regulatory compliance inspections is desirable.Knowledge, Skills and Abilities? Working knowledge of GMP regulations.? Ability to adapt, work flexibly, and thrive in a highly collaborative environment? Ability to work in a fast-paced, start-up environment. ? Work independently with minimal supervisory guidance,? Exhibit strong teamwork skills? Possess strong attention to detail.? Capable of being organized and managing multiple projects and responsibilities simultaneously.? Ability to prioritize projects/responsibilities? Possess good organizational and problem-solving skills.? Knowledge of Microsoft Office suite (Excel, Word, PowerPoint).? Good oral, written, and interpersonal communication skills.
