Quality Control Analyst I, Microbiology

Resilience.com

Boston, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 04/04/2021
  • Website: resilience.com
  • Company Address:

About Resilience.com

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.

Job Description

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

The QC Analyst I will report to the QC shift Supervisor in the Allston Quality Control laboratory and will contribute to general operations and testing of the QC Microbiology laboratory. QC Analyst I works independently under general supervision. Primary responsibilities include, but are not limited to the following: collect and process samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and final products in accordance with SOPs and CGMP regulations; review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development  of test methods and participate with the team to meet group goals and perform routine laboratory duties.

The shift schedule is Sunday through Wednesday, from 6AM-4:30PM.

Job Responsibilities

  • Perform Water, Steam and Critical Utility collection as well as associated testing
  • Perform Biological Indicator Testing
  • Perform Environmental Monitoring
  • Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric)
  • Perform Bioburden Testing of In-process products, buffers, and water
  • Receipt of manufacturing samples into the QC lab as well as sample retain disposal
  • Autoclave QC micro equipment
  • Troubleshoot assay and instrument problems with Laboratory Supervisor
  • Enter and review data in LIMS
  • Perform safety and operational  lab audit
  • General maintenance of Lab equipment
  • Participate in writing and revising SOPs, protocols
  • Assist in the development and optimization of testing methods
  • Maintain log books related to inventory and equipment
  • Ensure labs are clean and safe (in compliance with CGMP) and properly stocked
  • Make detailed observations in support of Alert, Action and OOS result investigations
  • Participate in the qualification of equipment, methods, and processes

Qualifications

  • Proficient in lab based data management systems
  • Possess strong scientific technical writing ability.
  • 1+ Year Experience in a CGMP lab environment
  • Experience with environmental monitoring including water testing

Preferred Experience

  • Associate’s or Bachelor’s Degree in Life Science discipline is preferred
  • Prior industry experience required
  • Experience with Microsoft Office Suite (Word, Powerpoint, Excel)

 

COVID 19 Alert – Resilience is closely monitoring the Coronavirus Disease (COVID-19). With a focus on candidate and employee safety, we have implemented a temporary process change shifting all in person interviews to be conducted virtually until further notice. 

Equal Opportunity Statement

At Resilience, we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, inclusive benefits, and more. Resilience is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. Resilience welcomes all.

Resilience does not accept unsolicited headhunter and agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.