Scientist I, Environmental QC

AbelZeta Inc is a biopharmaceutical company focusing on the development of novel cell therapy products for the treatment of advanced solid and hematological malignancies. The Scientist I, Environmental QC is responsible for performing a variety of environmental technical duties in support of the routine operation of AbelZeta Rockville GMP facility for IND and Phase I/II GMP manufacturing. This position will serve as a SME in environmental monitoring, ensuring the regulatory compliance of the GMP facility in collaboration with other functional groups.

Responsibilities and Duties:

• Execute daily environmental sampling for dynamic or static environmental monitoring (EM) of cleanrooms.
• Perform incubation, enumeration and gram staining of microbiological organisms.
• Perform growth promotion testing for media release.
• Document and maintain required QC records and logs.
• Trend and analyze EM data.
• Report and participate in the investigation of EM excursions, deviations, out-of-specification results, etc.
• Perform preparation and shipment of EM related samples to external contract testing laboratories when necessary.
• Write technical documents such as reports, change controls, and SOPs.
• Perform visual inspections and release testing on materials as needed.
• Other duties as assigned.

Qualifications and Requirements:

• Bachelor of science in a Life Sciences or related discipline.
• 2-5 years of relevant experience working in a Quality Control work environment, preferably in a regulated environment in the pharmaceutical/biotech industry.
• Working knowledge of cGMP regulations.
• Experience working and gowning in a cleanroom environment.
• Aseptic behaviors training

Preferred Qualifications:

• Ability to work in a fast-paced environment with little supervision.
• Ability to manage multiple and varied tasks and prioritize workload.
• Flexibility and adaptability to adjust to changing priorities and unforeseen events.
• Attention to details.
• Excellent time management skills.
• Excellent communication and interpersonal skills
• Ability to work evenings and weekends as needed.

Why You Should Join AbelZeta

• Join a high growth and fast paced organization
• Defined career path and annual performance review and feedback process
• Comprehensive Benefits Plan, including 100% company paid Medical, Dental, Vision, Life Insurance, Short-Term & Long-Term Disability insurance, and more!
• Competitive company 401k match
• Paid holidays, sick leave, and annual leave

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.