QC Associate – Environmental Monitoring & Sample Management

Pride Health; Bothell (WA); Presencial; USD 48.000 - 53.000; Jornada completa

Descripción de la vacante

Pride Health seeks a QC Associate – Environmental Monitoring & Sample Management to support GMP cell therapy manufacturing. You will perform environmental monitoring in cleanrooms, manage GMP samples, and ensure data integrity while adhering to GDP/GMP requirements.

The role requires a bachelor’s degree in biology or microbiology and 2 years of GMP experience, with on-site work in Bothell, WA. Weekend or extended shifts may be needed as required.

Formación

• Bachelor's degree in biology, microbiology or related science field.
• 2 years of laboratory or GMP experience.
• Basic understanding of environmental monitoring concepts.

Responsabilidades

• Perform routine environmental monitoring of classified manufacturing areas (Grade A–D).
• Manage GMP samples: receipt, logging, storage, distribution, and documentation.
• Ensure proper labeling, incubation, and documentation of EM samples.
• Initiate and lead excursion investigations and contribute to trend reports.
• Support deviations, investigations, and CAPAs related to EM or sample management.

Conocimientos

Environmental monitoring

GMP knowledge

Documentation

Educación

Bachelor's degree in biology/Microbiology

Herramientas

LabVantage

LabWare

Descripción del empleo

Pride Health is seeking a QC Associate – Environmental Monitoring & Sample Management for a clinical-stage cell therapy company, that develops T cell reprogramming technologies for patients with solid tumors.

Job Title: QC Associate – Environmental Monitoring & Sample ManagementLocation: Bothell, WA 98021 (on-site)Job Type: ContractLength: 12-MonthsShift: Sund-Wednesday 10 hrs. shiftPay Rate: $35.00 - $38.46 per hour

Summary:

We are seeking a highly motivated, detail-oriented QC Associate I/II– Environmental Monitoring & Sample Management to support Quality Control operations within a GMP cell therapy manufacturing environment. This role is responsible for performing environmental monitoring (EM) of classified cleanroom areas and managing GMP samples including receipt, logging, storage, and distribution for testing. The position ensures compliance with GMP regulations, internal procedures, and data integrity requirements while supporting the release testing of cell therapy products. The ideal candidate will have experience performing environmental monitoring and/or sample management in a GMP-regulated facility. products.

Responsibilities:

• Perform routine environmental monitoring of classified manufacturing areas including Grade A to Grade D cleanrooms.
• Experience with electronic systems (e.g. MODA) is a plus.
• Conduct viable and non-viable monitoring using:Active air samplingSurface contact platesParticle counters
• Perform personnel gowning qualifications.
• Support cleanroom requalification and special monitoring activities as required.
• Support Aseptic Processing Simulations (Client) and Aseptic Technique Qualification (ATQ) operations.
• Ensure proper labeling, incubation, and documentation of EM samples.
• Initiate and lead excursion investigations.
• Assist with trend reports and data entry for environmental monitoring results.
• Participate in internal audits, inspections, and training programs.
• Maintain accurate sample inventory and chain-of-custody records in electronic systems.
• Receive, log, track, and store incoming GMP samples from manufacturing, stability programs, and external sources. Use of an electronic system such as LabVantage or LabWare is a plus.
• Distribute samples to QC laboratories for testing.
• Support cleanroom and testing laboratories readiness activities including inventory management.
• Coordinate sample shipment to external testing laboratories when required.
• Support deviations, investigations, and CAPAs related to EM or sample management.
• Complete documentation in accordance with Good Documentation Practices (GDP) and GMP regulations.

Requirements:

• Bachelor's degree in biology, Microbiology or related science field or equivalent experience
• 2 years of laboratory or GMP experience
• Basic understanding of environmental monitoring concepts
• Strong attention to detail and documentation accuracy.
• Ability to work in cleanroom environments and gown in full aseptic gowning (cleanroom gowning including masks, gloves, and coveralls) for extended periods.
• Ability to work flexible hours including weekends or shifts if required.
• Ability to stand, walk, and perform repetitive tasks.Ability to lift up to 25 lbs.

Additional Information:

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible weekend work, and holiday work will occasionally be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients. During the onboarding and training period, training may occur on a different shift.

Benefits that Pride Health offers:

Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.