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Full-timeDescription
SUMMARY
The Quality Control Associate I, Lab Control 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
? Perform routine QC responsibilities as assigned by supervisor such as:? Support control and management of samples by receiving, aliquoting, and processing samples within QC.? Conduct routine and non-routine analyses of GMP product and raw material as assigned using appropriate analytical methods.? Perform peer review of test results.? Additional QC responsibilities include laboratory and equipment maintenance, QC document management, QC inventory control, contract lab coordination, and reconciliation of sample requests/documents as needed.? 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.? Assist in Analytical Development tasks and projects as assigned.? Compile data for documentation of test procedures and preparation of reports.? 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.? Apply acceptable cGMP practices during execution of all work tasks.? Work independently with minimal supervisory guidance.
Exhibit strong teamwork skills.? Regularly update management on status of testing and projects. Seek additional guidance as needed.Requirements
Education and Experience
? BS or advanced degree in chemistry, biology, biochemistry or related life sciences discipline.? BS with 0-3 years’ experience in Quality Control within GMP biopharmaceutical or biotechnology industry. Experience with regulatory compliance inspections is desirable.
Knowledge, Skills and Abilities
? Working knowledge of GMP regulations.? Experience with sampling and testing in a GMP manufacturing facility.? Ability to adapt, work flexibly, and thrive in a highly collaborative environment? Ability to work in a fast-paced, start-up environment. ? Strong attention to detail.? Capable of being organized and managing multiple projects and responsibilities simultaneously.? Ability to manage multiple projects and priorities, good organizational and problem solving skills.? Knowledge of Microsoft Office suite (Excel, Word, PowerPoint).? Good oral, written, and interpersonal communication skills.Salary Description$50,150 - $60,000
