QC Associate Scientist

Location
Redmond, WA
Posted
Jun 29, 2022
Ref
REQ-05856
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Just is seeking a motivated and creative Associate Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone to join a fast-paced, collaborative, and multidisciplinary team to provide collection and testing of environmental monitoring and water system samples as well as microbiological analysis of raw material, in-process and drug substance testing in support of our GMP manufacturing operations at our new Redmond Ridge facility. The successful candidate will have experience with aseptic technique and will have worked in a microbiology lab or taken upper level microbiology coursework. Experience with environmental monitoring including water sampling and testing is a plus. The ideal candidate has a high attention to detail, is organized in their work and works well independently and in teams.

Responsibilities:

  • Required to travel to both the Redmond, WA and the Seattle, WA facility, as applicable
  • Work with team members to support the GMP QC Laboratory operations
  • Perform QC Microbiology testing in support of the Facility Qualification Activities as well as the GMP manufacturing schedule including:
    • Environmental Monitoring
    • Water sampling and testing (Bioburden, Endotoxin, Total Organic Carbon and Conductivity)
    • Product Testing (Bioburden and Endotoxin)
    • Microbial Identification
    • Growth promotion testing for qualification of microbial culture media
    • Microbiological method validation testing for new products
  • Equipment validation (IQ, OQ, PQ)
  • Maintain laboratory equipment
  • Maintain laboratory supplies
  • Assure timely completion of GMP documentation
  • Maintain metrics and contribute to routine EM trending and trending summary reports.
  • Must demonstrate flexibility in adjusting to changing priorities and schedules.
  • Collaborate with other team members to ensure the quality task is performed in timely manner.
  • Must demonstrate flexibility in adjusting to changing priorities and schedules.
  • Perform investigations, and perform other general duties associated with the position as required by supervision.

Requirements:

  • BS in Microbiology, Biology or related field and 0-3 years experience
  • Experience or coursework in Microbiology
  • Experience with Microsoft Office apps (Word, Excel)
  • Good interpersonal skills, hands on, analytical, and problem solving and decision-making skills.
  • Excellent communication skills (oral and written) and data management skills
  • Strong adherence to data integrity requirements
  • Good computer skills, including utilizing personal computers and data entry programs.
  • Ability to work independently and with others to accomplish goals and priorities.
  • Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team
  • Ability to interact constructively with co-workers
  • Flexibility and teamwork skills, high level of energy and regular, consistent attendance.
  • Good organizational skills with attention to detail
  • Ability to understand analytical/technical data
  • Ability to learn regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to environmental monitoring
  • Must possess good hand-eye coordination.
  • Ability to wear various personal protective equipment (PPE) including full cleanroom gowning in support of ISO-8, ISO7 and ISO-5 workspaces as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
  • Ability to use various cleaning and disinfectant agents
  • Required to stand or sit for long periods of time while performing duties.
  • Must be able to stand 8+ hours a day.
  • Responsibilities also include the ability to lift heavy objects (up to 50 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach without accommodation.
  • Exposure to medium noise levels.

Preferred qualifications:

  • Experience with environmental monitoring
  • Experience with water sampling and testing (bioburden, endotoxin, TOC and conductivity)
  • Experience with microbial identification
  • Strength in data science and informatics


Worker