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.

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.