Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant

experience in leading all Document Control management activities related to the manufacturing of biological products from Phase 1 to PPQ to commercial. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.

Responsibilities:

• Issues production batch records and labels to support manufacturing operations.

• Serves as primary point of contact for site functional areas regarding documents and label controls.

• Responsible for issuance of final product labels, batch record and other controlled documentation.

• Supports the development and deployment of document control tools.

• Responsible for the management of document control room at site and archival of documentation

• Executes the scanning and “true copies “process for the production batch records.

• Supports internal and external client audits and regulatory inspections. Including but not limited to SME for document control and document retrieval during regulatory inspections.

• Performs routine and ad hoc labeling and issuance metric reporting and analysis for the local site data.

Educational Requirements:

• Bachelors degree in biological or engineering science with 3+ years relevant experience

Preferred Qualifications:

• Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company

• Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES

• Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams

The base pay range for this position at commencement of employment is expected to be $90,000 to $150,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.