QA Manager - Document Control

Manager, Document Control | Just. – Redmond, WA |

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:

• Lead and direct all aspects of the Document Control function at site to assure compliance with quality and industry regulatory requirements.
• 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.
• Writes and maintains the label and batch issuance procedures.
• Leads and participates in the development and deployment of document control tools.
• Responsible for the management of document control room at site and archival of documentation
• Responsible for managing and executing the “true copies “process for the production batch records.
• Develops and delivers training regarding process or system changes.
• 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.
• Provides communication as to the status of deliverables to customers, management and stakeholders.
• Responsible for managing the Document Control team, including recruitment and performance management.

Educational Requirements:

• Bachelors degree in biological or engineering science with 8+ years relevant experience

Preferred Qualifications:

• Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company
• Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making
• Expertise in tools, concepts, and methodologies of QA
• 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

About Just

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood and first North American J.POD® commercial manufacturing facility in the Seattle area.

The base pay range for this position at commencement of employment is expected to be $115,000 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.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.