Analyst I, QC Micro-2nd Shift

Bora Pharmaceuticals; Baltimore (MD); On-site; USD 47,000 - 71,000; Full time

Job summary

An established industry player seeks a dedicated Analyst I for their Quality Control team on the 2nd shift. This role involves conducting critical microbial analyses and environmental monitoring to ensure the quality and safety of drug products. As part of a dynamic team, you'll engage in various testing procedures, data analysis, and SOP development. Ideal for recent graduates, this position offers a unique opportunity to start your career in the pharmaceutical manufacturing sector, contributing to essential quality assurance processes in a supportive work environment.

Qualifications

• Technical knowledge in microbiology and aseptic processing.
• Experience in QC and environmental monitoring in pharmaceuticals.

Responsibilities

• Conduct microbial analyses and environmental monitoring.
• Perform microbiological testing and prepare sterilization materials.
• Write and review SOPs and testing standards.

Skills

Microbiological Testing

Environmental Monitoring

Data Analysis

SOP Writing

Communication Skills

Planning and Organizational Skills

Stress Tolerance

Education

BS in Microbiology/Biology

Tools

LIMS

Autoclave

Job description

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Job Description

I. JOB SUMMARY

Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing, and stability of drug products and incoming raw materials. This position supports our 2nd shift, working 2pm-10:30pm, Monday through Friday.

II. Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Perform microbiological testing procedures as per batch records, protocols, and raw material requests.
• Conduct environmental monitoring and utility testing of the facility.
• Perform environmental monitoring during fill operations.
• Operate a biohazard trash autoclave.
• Perform daily equipment checks.
• Stock and clean the lab and equipment daily.
• Prepare materials requiring sterilization.
• Inform supervisor/manager of OOS, OOL, or deviations.
• Participate in validation and troubleshooting of equipment.
• Write and review SOPs and testing standards.
• Review, analyze, interpret, and report data.
• Verify and enter results in LIMS.
• Prepare disinfectant solutions, reagents, and samples.
• Participate in investigations and related studies.
• Practice good documentation and safety procedures.
• Track time worked per project.
• Attend professional seminars and conferences.
• Participation in biomedical screening is required.

III. Minimum Education, Experience, Skills

To perform successfully, demonstrate:

• Technical/professional knowledge in related areas.
• Clear and persuasive communication skills.
• Planning and organizational skills.
• Safety awareness and proper equipment use.
• Adaptability to changes.
• Stress tolerance under pressure.

Education: BS in Microbiology/Biology or related field.

Experience: 0-2 years in pharmaceutical or biotech, focusing on aseptic processing, QC, microbiology, environmental monitoring, water systems, validation, or manufacturing.

IV. Physical/Mental Demands & Work Environment

Must meet physical and mental demands to perform job duties. Work environment characteristics are typical for such roles.

Compensation Range

$47,077.00 - $70,615.00

Bora Pharmaceuticals is committed to equal employment opportunity and nondiscrimination in all employment practices.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing