Manufacturing Associate

Spectraforce Technologies; Bothell (WA); On-site; USD 52,000 - 68,000; Full time

Job summary

Spectraforce Technologies, Inc. in Bothell, WA is seeking a Manufacturing Associate to support cell therapy manufacturing operations in a GMP environment.

You will work on a 12-month assignment, Sundays to Tuesdays from 11:00 AM to 11:30 PM with alternating Wednesdays, all onsite, contributing to safety, quality, and cGMP compliance while collaborating with a cross-functional team. The role requires meticulous attention to detail, ability to follow SOPs, and readiness to work across shifts to

Qualifications

• Associate or bachelor's degree in related field is preferred.
• A minimum high school diploma and/or equivalent combination of education and experience is required.
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education.
• 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.

Responsibilities

• Learn and execute Cell Therapy Manufacturing operations compliantly
• Execute operations per Source Governing Documents, SOPs, Work Instructions, batch records and 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 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
• Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements

Job description

Position Title: Manufacturing Associate

Work Location: Bothell, WA

Assignment Duration: 12 Months

Work Schedule: Sunday-Tuesday 11:00 AM-11:30 PM alternating Wednesday

Work Arrangement: 100% Onsite

Position Summary: Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

Key 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
• Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements

Qualification & Experience

• Associate or bachelor's degree in related field is preferred
• A minimum high school diploma and/or equivalent combination of education and experience is required
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• 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

Working Conditions & Physical Demands (If Applicable)

• Must be able to stand/walk for extended periods of time
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection
• Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
• Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
• Work in areas that may have strong magnets
• Must be able to work in a BSL2 / ML1 work environment handling human blood components
• Work in areas with exposure to vapor phase liquid nitrogen
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)

Additional Information (If Applicable)

Position Handles Hazardous Materials