Analyst II, QC Microbiology-2nd Shift

Bora Pharmaceuticals; Baltimore (MD); On-site; USD 56,000 - 86,000; Full time

Job summary

An established industry player seeks a dedicated Analyst II for QC Microbiology. This pivotal role involves supporting quality control efforts, conducting microbiological testing, and ensuring compliance with aseptic processes. The successful candidate will thrive in a dynamic environment, collaborating with project managers and QA teams to uphold the highest standards of quality and safety. With opportunities for professional growth and a commitment to diversity, this position is ideal for those looking to make a significant impact in the pharmaceutical sector. Join a forward-thinking company where your skills will be valued and your contributions recognized.

Qualifications

• 2-4 years experience in Pharmaceutical or Biotechnology sectors.
• Knowledge of QC Microbiology and cGMP environments.

Responsibilities

• Perform microbiological testing and environmental monitoring.
• Support aseptic filling operations and maintain qualifications.
• Investigate and report deviations and issues.

Skills

Microbiological Testing

Environmental Monitoring

Aseptic Processing

Problem-solving

Technical Writing

Communication Skills

Planning and Organization

Education

BS in Microbiology/Biology

Tools

Excel

Word

LIMS

SAP

Job description

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Job Summary
The Analyst II, QC Microbiology position supports the Quality Control group at Bora Pharmaceuticals Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, including microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision.

This position supports the 2nd shift, working 2pm-10:30pm, Monday-Friday.

Essential Functions

• Achieve gowning and aseptic qualification within 4 months.
• Maintain aseptic qualification and support aseptic filling operations, supporting aseptic operations up to 50% of the time.
• Maintain gowning qualification.
• Perform microbiological testing procedures as per batch records, protocols, and requests.
• Conduct environmental monitoring and utility testing of the facility proficiently.
• Work with Project Managers and QA for timely testing and sample release.
• Report OOS, OOL, or deviations to supervisor/manager.
• Participate in investigations of OOS results and related studies.
• Assist in validation and troubleshooting of equipment, resolving instrument issues proactively.
• Investigate and suggest improvements for laboratory procedures/techniques.
• Validate and implement new laboratory procedures/techniques.
• Update or create testing standards and SOPs.
• Train Microbiologist I & II in methods and techniques.
• Review, analyze, interpret, and report data.
• Practice Good Documentation and Laboratory Safety procedures.
• Support departmental compliance and productivity goals.
• Write and review monthly reports as needed.
• Track time per project.
• Manage Change Controls and related actions.
• Conduct deviation investigations.
• Proficiently use document management systems and update procedures.
• Perform Aseptic Technique/Contamination Control Training.
• Observe and report issues during filling operations.

Minimum Education, Experience, Skills

Education

BS in Microbiology/Biology or related field.

Experience

2-4 years (MS with 0-2 years) in Pharmaceutical or Biotechnology sectors, focusing on aseptic processing, QC microbiology, environmental monitoring, water systems, validation, or manufacturing processes.

• Technical/Professional Knowledge of microbiology and cGMP environments.
• Problem-solving skills to resolve issues timely.
• Safety awareness and proper equipment use; ability to lift ~25 lbs.
• Effective communication and group presentation skills.
• Commitment to quality, accuracy, and thoroughness.
• Strong planning, organization, and adaptability skills.
• Ability to handle stress and maintain performance under pressure.

Knowledge

Knowledge of QC Microbiology, cGMP, aseptic gowning, and proficiency in microbial testing and environmental monitoring.

Skills

Intermediate skills in Excel and Word, technical writing, and report review. Ability to develop and review SOPs and testing standards.

Abilities

Effective communication, independent and team work, multitasking, training others, and familiarity with computer systems like Excel, Word, LIMS, or SAP.

Compensation Range

$56,919.00 - $85,379.00

Bora Pharmaceuticals is an equal opportunity employer, committed to diversity and inclusion in hiring and employment practices.