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Quality Control Microbiologist Aseptic Specialist
4 weeks ago
The Quality Control Microbiologist Aseptic Specialist is responsible for ensuring the microbiological quality of Perspective Therapeutics' products and processes. This role involves advancing aseptic awareness, contamination control strategy, and site practices while adhering to all applicable regulations and standards.
Key Responsibilities
- Establish and evolve a contamination control strategy for aseptic manufacture and supply of clinical trial radiopharmaceutical drug products.
- Oversee aseptic and microbiological training of site staff.
- Conduct microbiological testing of raw materials, in-process samples, finished products, and environmental monitoring samples.
- Perform sterility testing, endotoxin testing, microbial limits testing, and other relevant assays in accordance with SOPs and cGMP guidelines.
- Lead, write, and execute protocols/reports for new or changes to processes or procedures as well as investigations related to sterility assurance.
- Qualify instruments, validate QC laboratory methods, evaluate new materials/products, and establish testing standards.
- Responsible for calibration and maintenance of equipment, lab supplies inventory, and related vendor coordination, POs/budgeting.
- Assist with inspection readiness and act as department SME during audits/regulatory inspections, author responses.
- Utilize a range of electronic systems such as document/equipment management software, QMS, LIMS, and ERP (if applicable).
- Author, review, and act as document owner for procedure changes; take QC lead on change controls, CAPAs, and other quality system requirements.
- Represent Quality Control in team meetings and projects (inter & cross-functional), providing technical perspective and expertise.
Requirements
To perform this job successfully, an individual must have a BA/BS degree in Microbiology, Biochemistry, Biological Sciences, or a related field; Master's degree preferred. Minimum of 5 years of experience in a microbiology laboratory, within the pharmaceutical or radiopharmaceutical industry. Familiarity with regulatory requirements and guidelines (e.g., FDA, EMA, USP, EP). Experience performing bioburden and sterility tests, and environmental monitoring using EM Total Particulate/Viable monitors, and other required equipment/materials. Experience in a GMP compliant manufacturing following ALCOA+ principle and 21 CFR 211 guidelines is highly preferred. Radioactive material handling of gamma, beta, and alpha emitters experience preferred.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee must be willing to work in a facility producing radioactive materials. Note - employees are required to participate in safety programs designed to minimize potential and/or actual exposure levels. The employee must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed. The employee may be required to sit or stand for long periods of 8+ hours a day while performing duties. Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required. The employee must possess good hand-eye coordination; close attention to detail is required. The employee must be willing to complete safety training within allotted timeframes, and work in a team-based environment.
