Quality Analyst II, 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. 

This position is eligible for a $5,000 sign-on bonus for those that qualify!

Your Role:

As a Quality Analyst II in the Quality Control Microbiology group, you will support the site by performing environmental monitoring of the cleanroom manufacturing environment as well as microbiological testing of pharmaceutical grade water systems, raw materials, and production samples.

Environmental Monitoring responsibilities 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.

Laboratory Testing responsibilities include, but are not limited to, bioburden testing, endotoxin testing, media fill testing, growth promotion testing, and biological indicator testing.

The Carlsbad Viral Vector Manufacturing Facilities are a CDTMO focused on viral vectors and gene therapies. The role will entail operating in a fast-paced, highly dynamic environment in collaboration with other departments as well as external stakeholders. A role in Quality Control offers the opportunity to work with and learn about all the different aspects of the organization, from Facilities to Validation to Manufacturing and Quality Assurance.

Operators in this role will:

• Follow company EH&S requirements
• Promote a safety-first culture
• Ensure that all required documentation (raw data, testing records, and logbooks) are 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 as needed
• Report deviations and nonconformances through the quality management system
• Lead and support investigations into nonconformances and deviations
• Lead and support revision processes for SOP’s and other related documentation as needed
• Train new operators
• Support the protocol execution for special studies and projects as needed
• 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
• 2+ years of experience in Pharmaceutical Environmental Monitoring and/or Quality Control Microbiology Testing
• 1+ years of experience with data entry and graphing using Microsoft Excel

Preferred Qualifications:

• Bachelor’s Degree in science, Chemistry, Biology or similar life science discipline
• Highly proficient with Microsoft Word and Excel
• Experience with cGMP, Quality Control, aseptic techniques, microbiology testing, Laboratory Information Management Systems (LIMS), 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 - $42,300 - $98,700

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