Manufacturing Associate I - Bothell WA

Duties and Responsibilities

• Learn and execute Cell Therapy Manufacturing operations compliantly
• Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)
• Executes transactions and process in all electronic systems and adheres to business continuity processes
• Prioritizes safety of self and others
• Reports safety events within 24 hours
• Immediately escalates any/all issues that may impact compliance or safety of self and/or others
• Complete documentation required by Source Governing Documents contemporaneously
• Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+
• Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge
• Train for proficiency in process systems and some supporting business systems
• Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts
• Work within a control cleanroom environment and execute aseptic processing procedures (as assigned)
• Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
• Continues to refine and improve manufacturing process technique to improve individual operational times
• Verifies training completion prior to performing any GxP tasks
• Autor Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements

Requirements

• Bachelor’s degree in related field preferred
• Minimum high school diploma and/or equivalent combination of education and experience is required
• Proven experience working on teams where collaboration and results were expected
• Proficiency in common computer tools such as word processing, spreadsheet and web-based applications
• Meticulous attention to detail and personal accountability is critical to success
• Possess excellent interpersonal skills, is attentive and approachable
• Maintain a professional and productive relationship with area management and co-workers
• Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred

Qualifications

• High School/GED

Skills

• Good Manufacturing Practices (GMPs)
• Cell Therapy Manufacturing
• Bioprocessing Manufacturing

Benefits

N/A

Pay

$30.61 - $37.09 per hour

Schedule

Thu – Sat (alt. Wed) 1100 - 2330