Analyst II, Quality Control

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Job Responsibilities:

• Performs Environmental Monitoring (EM) of Controlled Classified Areas
• Performs compendial assays such as Bioburden Test, media Growth Promotion Test, Sterility Tests and Biological Indicators (BI) analysis
• Perform method suitability tests
• Utilities Monitoring (UM) and Testing for Bioburden and Bacterial Endotoxin
• Performs Microbial Isolations and Identification Tests 
• Supplies inventory and lab organization
• In-process and finished product samples to include bioburden, bacterial endotoxin, and sterility.
• Raw material testing for specific microbial requirements.
• Routinely gown and maintain certifications for all classified/controlled manufacturing areas.  Keep and maintain cGMP certification.
• Environmental Monitoring of cleanrooms and dynamic processes including viable air sampling, surface sampling, non-viable air sampling, and personnel monitoring.
• Sampling and analysis of purified water, Water for injection and clean steam.
• Sampling and analysis of compressed gases and air.
• Biological indicator receipt, issuance, and analysis.
• Media fill inspection 
• Growth promotion of media and media fill units.
• Perform microbial identifications, evaluating and interpreting results to identify objectionable organisms from environmental monitoring and product testing.
• Demonstrate the ability to understand and interpret test results and use the results to decide with regard to acceptance of the associated criteria and requirements.
• Conduct laboratory deviation investigations developing CAPA’s for non-conformances/excursions
• Perform data entry and understanding of trend reports
• May perform role of Administrator for lab-based software. 
• Identifying and purchasing the necessary supplies needed to support laboratory needs.
• Training other employees on tasks where the Analyst 1 is an SME or trainer.
• Other duties as assigned.

 
Minimum Qualifications: 

• Experience in GMP QC Laboratory operations, ideally doing Environmental Monitoring (EM) for Viable and Non-Viable Particulate and Utilities Monitoring (UM) and testing and/or any other Microbiological Testing.

 
Preferred Qualifications: 

• Bachelor’s degree on Science/Biology/Microbiology

Physical Requirements:

This job requires the employee to perform the following physical activities: 

•    Balancing

•    Use of Fingers

•    Stooping

•    Kneeling

•    Repetitive motion

•    Crouching

•    Reaching

•    Standing

•    Grasping

•    Walking

•    Pushing    

•    Hearing

•    Pulling    

•    Lifting

•    Talking
 
This job requires the employee to work in the following conditions:

•    Typical Office Environment

This job requires exposure to the following:

•    Laboratories

•    Production rooms

•    Waste holding areas

•    Other facilities where infections agents are, or may be handled &/or stored
 
This job requires the employee to perform the following type of physical work:

•    Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
 
This job requires the following visual acuity requirements:

•    Eye correction for visual inspection of samples after incubation.
 
This job requires routine or periodic use of respiratory protection:

•    Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).

•    Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.

Resilience is an Equal Employment Opportunity 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