CEL - QA Specialist Quality Engineering at NTT Data Services in Bothell, Washington

Job Description:

12 months to start contract



Job Description: The Quality Engineering team at Juno is responsible for providing Quality Assurance oversight of **Environmental** validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. The position of QA Specialist - Environmental Oversight reports to the Manager, Quality Engineering. This position is based at the Juno Manufacturing Plant (JuMP) located in Bothell, WA.



PRIMARY RESPONSIBILITIES

• Provide oversight of cleanroom environmental programs including environmental monitoring (EM), cleaning and sanitization, and facility controls.

• Review and approve complex documentation in support of GMP operations at JuMP, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.

• Proactively identify and resolve technical and compliance issues/gaps.

• Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.

• Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)

• Collaborate with stakeholders within and outside of the JuMP Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports



REQUIRED QUALIFICATIONS

• **REQUIRES an environmental or microbiological QC background** (don't submit candidates without this)

• Having some knowledge of validation process (for facilities & utilities) would be a PLUS

• Strong individual contributor with demonstrated ability to work independently

• Minimum of 8-10 years working in a Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization

• Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy

• Direct experience with providing cleanroom guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred

• Experience in Systems related to validation, calibration, maintenance, change control, and deviations strongly preferred

• Excellent communication, trouble shooting, and problem solving skills



EDUCATION REQUIREMENTS

• Bachelor's degree in a STEM discipline, additional disciplines may be considered if combined with relevant experience





The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs.  The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law.  To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.