Location: Marlborough, MA (100% on-site)
Shift: Monday–Friday, 8:00 AM–5:00 PM
Contract Duration: 6 months, with potential for extension
Interview Process:
Initial virtual interviewSecond interview with two team members.Overview:
We are seeking an experienced and motivated Associate I, Quality Control Microbiology to join our team during a critical time as we prepare for the commissioning and qualification of our Marlborough facility. The ideal candidate will have prior experience in environmental monitoring, critical utility sampling, and gowning. This position requires minimal hands-on training, as resources are limited.
Key Responsibilities:
- Conduct routine environmental monitoring and critical utility sampling, including water and process gasses.
- Analyze water samples for Total Organic Carbon (TOC), Conductivity, Bioburden, and Endotoxin.
- Perform process gas testing for Total Particulates, Viable Air, Hydrocarbons, and Dewpoint.
- Execute microbiological testing of raw materials, excipients, drug substances, and finished products.
- Prepare and ship samples to contract laboratories, including those for microbiological identification.
- Support general lab activities such as equipment maintenance, housekeeping, and adherence to GMP standards.
- Contribute to equipment and method qualifications, validations, and transfers.
- Utilize Good Documentation Practices (GDP) for data entry and recordkeeping.
- Participate in the creation and revision of Standard Operating Procedures (SOPs).
- Assist in initiating and closing quality system records, including deviations and environmental monitoring excursions.
Basic Qualifications (Must-Have):
- Bachelor's degree in a relevant scientific discipline with 1–2 years of cGMP experience OR 5+ years of cGMP experience with a focus in Microbiology.
- Familiarity with environmental monitoring and critical utility sampling.
- Experience with gowning and working in a controlled environment.
Preferred Qualifications (Nice-to-Have):
- Willingness to learn and adapt in a fast-paced environment.
- Strong collaboration and communication skills.
- Curiosity and a desire for professional growth.
About You:
- You are detail-oriented and thrive in a dynamic environment.
- You demonstrate strong problem-solving skills and an ability to work independently.
- You align with values: Bold, Relentless, Curious, and Collaborative.
Additional Details:
- This is a full-time, site-based position with no eligibility for remote work.
- Visa sponsorship is not available for this role.
Join us at a pivotal moment in our journey and contribute to groundbreaking advancements in mRNA technology.