POSITION TITLE: Microbiologist II
REPORT TO: Microbiology Supervisor
Serves as the technical subject matter expert with regards to environmental control in an aseptic processing operation, and all other microbiology testing related to customer products and GRAM operations. The responsibilities of this position require effective cross-functional interaction at all levels, working within and leading teams to ensure compliance and drive continuous improvement of environmental control and microbiology testing.
• Leads and/or actively participates in technical projects pertaining to microbiology testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc.
• Performs method validation/ suitability for microbiological tests, specifically bioburden and endotoxin testing.
• Performs B&F and Sterility Testing in an Isolator.
• Performs trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable.
• Investigates and document any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective / preventive actions.
• Performs/reviews/approves Laboratory Investigations for any out of specification results.
• Performs/reviews/approves Environmental Investigations.
• Plans and implements corrective and preventive actions (including procedure and test method revisions), and assist/measure the effectiveness of such changes.
• Assesses process / procedure changes proposed by others for potential impact on environmental monitoring / microbiology testing processes.
• Participates in cross-functional meetings and training sessions with manufacturing operations
• Authors technical protocols and reports for QC Microbiology.
LABORATORY SUPPORT ACTIVITES:
• Maintains qualification for all microbiology sampling procedures and test methods; perform testing as needed to support business needs.
• Coordinates and/or conducts training for new laboratory personnel; provide technical assistance to laboratory personnel as needed.
• Coordinates with contract testing laboratories and experts as needed.
• Reviews process and testing documentation as needed to ensure complete and accurate records are maintained.
• Assists in the conduct of vendor audits as a microbiology subject matter expert, as needed.
• Participates in client and regulatory audits as a microbiology subject matter expert, prepares documents for review and speaks to GRAM processes and procedures to answer auditor questions.
• Supports Agency, customer and vendor audits as needed.
• Performs all other tasks, projects, and duties as assigned.
• Bachelor’s Degree in Microbiology or a related field and a minimum of 8 years’ experience in a Microbiology laboratory supporting an aseptic manufacturing process.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Ability to interpret and translate Quality standards to ensure effective implementation.
• Organized, self-motivated, individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Strong written and verbal communication skills
• Ability to communicate effectively with management, staff, vendors, clients, and regulatory agencies.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .