Quality Analyst 1 - Microbiology

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

As a Quality Analyst I in the Quality Control Environmental Monitoring group, you will support the site by testing the quality of the cleanroom manufacturing environment and ensuring that SAFC Carlsbad adheres to strict regulatory and ISO requirements.

Monitoring activities include but are not limited to, collecting surface, air, water, and personnel samples, monitoring manufacturing processes, enumerating microbial plates, data entry, trend analysis, reporting deviations and nonconformances, and investigation support. The role will entail operating in a fast-paced, highly dynamic environment in collaboration with other departments as well as external stakeholders.

This role will support the daily operations of the Environmental Monitoring Group, collect samples, process samples, complete documentation, enter data, and review data for Environmental monitoring.

• Comply with company EH&S guidelines
• Promote a safety-first culture
• Ensure that all required documentation (raw data, testing records, and logbooks) is completed accurately per Standard Operating Procedures (SOPs) and entered in a timely manner
• Perform basic maintenance, such as equipment setup and cleaning as well as stocking/inventory of materials and consumables
• Perform autoclave sterilization 
• Report deviations and nonconformances through the quality management system
• Support investigations into nonconformances and deviations
• Support SOP revision processes and other related documentation 
• Support the protocol execution for special studies and projects 
• Prioritize tasks to ensure that projects are completed by the assigned deadlines
• Support team building by participating in interviewing new talent
• Responsible for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions

Physical Attributes:

• Wearing PPE when entering the cleanroom space. PPE includes, safety glasses, face masks, hoods, scrubs, sterile gowns, gloves, sleeves, and boot covers
• Sit and reach to use computers and other office/lab equipment
• Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
• Occasionally lift up to fifty (50) pounds
• View objects at close and distant ranges
• Occasional exposure to fumes, airborne particles, chemicals, vibration, and biohazardous materials

Who you are:

Minimum Qualifications:

• High School Diploma or GED
• 1+ years of word processing software such as Microsoft Word
• 1+ years of data entry and graphing using Microsoft Excel

Preferred Qualifications:

• Bachelor’s Degree in science, Chemistry, Biology, or a similar life science discipline
• Experience with cGMP, aseptic techniques, microbiology testing, automation, troubleshooting for equipment, software, and data integrity
• Understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals
• Experience with Aseptic Technique and Gowning
• Coursework in Microbiology

Pay Range for this position - $36,500 - $85,300

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.  Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html