Chemist / Microbiologist

Role Summary

Chemist / Microbiologist responsible for supporting quality control and microbiological testing in a penicillin manufacturing environment. The role involves media preparation, culture management, sampling and labeling, data interpretation, and ensuring compliance with Good Manufacturing Practices and Good Laboratory Practices. Strong organizational skills and effective communication are essential to support safe, high-quality products for patients. Location: On Premise.

Responsibilities

• Assist in preparation of media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories by autoclave cycles.
• Assist in maintenance of Master cultures isolates and preparation of Cryo vials.
• Manage receipt, storage and handling of Bio ball cultures.
• Perform water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test and Assays, CCIT and micro challenge studies.
• Ensure training records are updated and correctly filed to reflect current testing capabilities.
• Perform sampling and labeling of materials as per defined procedure and verification of all the equipment / instruments.
• Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices (cGMP) impact and recommend appropriate corrective actions.
• Ensure all documentation and quality records are conducted in accordance to Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance to existing policies.
• Review and revise Standard Operating Procedures (SOPs), analytical methods and related procedures/documents, to keep them current.
• Perform analyses on finished products, raw materials, and components including entry, review, and/or approval of data in a computerized database and generate EMS reports.
• Conduct microbiological protocols on an as needed basis.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Qualifications

• Required: Bachelor's degree with 0+ years of experience; OR an Associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
• Required: Demonstrated technical skills in method validation and testing.
• Required: Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations.
• Required: Knowledge of Good Manufacturing Practices and its application standards, processes and policies.
• Required: Excellent organizational skills and strong ability to multi-task.
• Required: Strong written and verbal communication skills.
• Preferred: Laboratory work experience with analytical HPLC (High Performance Liquid Chromatography).
• Preferred: Experience leading continuous improvement projects.
• Preferred: Knowledge of lean manufacturing, six sigma methodologies, and statistics.

Education

• Bachelor's degree with 0+ years of experience; OR Associate's degree with 4 years of experience; OR High School diploma (or equivalent) with 6 years of relevant experience.

Skills

• Analytical thinking and data interpretation.
• Strong documentation and record-keeping abilities.
• Effective communication and collaboration within a team.
• Ability to multitask and manage competing priorities.

Additional Requirements

• Physical/Mental Requirements: Laboratory and office work require walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg. Must have the ability to maintain mental focus on complex challenges throughout a shift.
• Not allergic to penicillin (facility-specific requirement).
• Non-standard Work Schedule, Travel or Environment: There is no routine travel. Normal work hours are Monday through Friday from 8:00am - 5:00pm. Work outside core work hours will occasionally be required to support manufacturing, projects, investigations, etc., as required by business need.
• Work Location: On Premise. No relocation support available.