Microbiologist I

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

The Microbiologist I is responsible for evaluating material and product quality by performing various procedures in the microbiology laboratory. This individual performs analysis on Raw Materials, Finished Products, Stability, water, and environmental monitoring samples using established analytical methods and is responsible for developing new test methods for the QC Microbiology department.

Job Description

ESSENTIAL FUNCTIONS:

• Provide support for the various projects within the QC Micro Lab- Center of Excellence Department
• Assists in the testing of method development and validation for microbial testing
• Prepares and executes protocols for method development
• Assists in the implementation of new equipment
• Ability to support OOS Investigations providing root cause analysis and corrective action for Out of Specification Results
• Performs product bioburden testing on incoming raw materials and finished products, as needed
• Writes and revises microbiology and other relevant SOP’s, as required
• Takes an active role in laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, and auditing
• Assists in the training of new team members on testing procedures and compliance regulations. Primary contact for initial training for lab work and documentation.
• Rotates holidays and weekends as necessary to support a 24 hour production facility
• Prepares trend reports
• Completes organism identifications
• Assists with establishing & maintaining safe work standards in the laboratory
• Follows site HSE Policies
• Peer reviews all levels of work
• Follows good documentation practices for the accurate and timely documentation of all activities

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• LIMS entry of data, approval, and release of data
• Use of analytical balance, pH Meter, TOC Analyzer
• Maintain instrument readiness
• Perform change controls
• Ability to troubleshoot equipment and methods in areas of proficiency
• Mentor and trainer for all areas of proficiency

MINIMUM REQUIREMENTS:

Education:  Bachelor’s degree in an appropriate scientific discipline (e.g., microbiology, biology)

Experience:  Minimum of 3 - 5 years pharmaceutical microbiology experience in a cGMP facility or Master’s degree in an appropriate scientific discipline (e.g., microbiology, biology. At least 6 years related experience or equivalent technical experience may be considered toward the minimum experience requirement.

Preferred Skills/Qualifications:

• Ability to perform multiple tasks simultaneously with accuracy and precision with minimal supervision.

• Ability to establish priorities and demonstrate leadership.
• Good technical writing and oral communication skills with both team members and other plant support groups
• Can work on moderately difficult or demanding tasks and projects
• Computer literate with experience in MS Office
• Substantial acquaintance with and understanding of application of basic industry principles, theories and concepts

Skills/Competencies:

Self-motivated, Team Oriented, Informing, Customer Focus, Listening, Organizing, Function/Technical skills, Peer Relationships

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Reports to the Supervisor, Quality Testing. Contacts involve matters of moderate importance to the organization and include Quality Assurance, R&D, Marketing, Production Supervisors, Production Engineers, Production Lead Operators, Logistics, Safety, Regulatory, Training, Document Control and DEA.

WORKING CONDITIONS:

• 60% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds
• 40% Office environment
• Required to work 8 hour shifts, the potential for night, weekend, and holiday work depending on the needs of the lab
• 10-15% Travel

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.