2nd Shift Quality Control Analyst II Microbiology

About the Role

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent! We are seeking a 2nd Shift Quality Control Analyst II to join our expanding team.

The Quality Control Analyst II for the QC Microbiology Department will be responsible for performing routine environmental monitoring, product testing, and raw material testing. This position is dedicated to 2nd shift operations (typically 2:00 PM to 11:00 PM, with potential workweek configurations such as Sunday–Thursday or Tuesday–Saturday based on facility needs). Please note that comprehensive onboarding and training take place Monday through Friday, 8:00 AM to 5:00 PM, for approximately 3 to 4 months until Grade A sign-off is achieved prior to transitioning to the assigned shift.

The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills, shift handoff coordination, and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Performs sterility testing and endotoxin testing of raw materials, in-process samples and finished products
• Performs growth promotion of microbial media
• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• Prepares environmental monitoring excursion reports and conducts minor laboratory investigations.
• Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Assists the QC Supervisor/Leads with managing proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Maintains familiarity with QC-relevant current Good Manufacturing Practices (cGMP) guidance (CFR, USP, EP, ICH, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform other related duties as assigned

QUALIFICATIONS:

• Bachelors or higher degree in the biological sciences or related field preferred
• Minimum of 1-2 years relevant laboraty experience or experience in a cGMP/FDA regulated industry, or a combination of years of educated and relevant laboratory experience or experience in a cGMP/FDA regulated industry
• Demonstrated knowledge in Microbiology and aseptic techniques required
• Ability to work independently or as a team member
• Ability to work in Clean Room environment with full gowning requirements
• Ability to problem-solve and troubleshoot as necessary
• Detail-oriented with strong written and verbal communication skills
• Familiarity with laser particle counters, viable air samplers, microscope, Endosafe® Instrumentation, PCR, BacT/ALERT systems preferred
• Familiarity with laboratory data systems such as MODA, LIMS, etc preferred

COMPENSATION DATA:

The pay range for this position is $56,100 - $62,700 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Why Join Us?

Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company contribution.
• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.

Pay: $56,100.00 - $62,700.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person