Internal Title: Microbiologist
Shift: As it stands, this would be standard Monday - Friday role. But, we need candidates to flexible as business/project needs can change quickly.
Brief Job Description:
Performs tasks related to the quality of pharmaceutical products in the Microbiology Department.
• 4-year degree in Biology, Microbiology or related discipline and 3 years of experience in a regulated or cGMP environment.
• 2 years of experience supporting microbiological testing in a sterile pharmaceutical operations environment
• Prepare documentation of activities, actions, and/or results.
• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Complete required training.
• Ensure proper documentation practices during job activities.
• Perform visual inspections.
• Verify count, measure and check materials to ensure proper components, quantities, and/or characteristics.
• Conduct troubleshooting activities.
• Train others on systems, software, equipment, machines, procedures, and/or processes.
• Answer compliance and process questions from others.
• Communicate policies and procedures to employees.
• Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
• Gather, organize, and communicate operational information to others.
• Lead and coordinate investigations and studies with little supervision.
• Communicate priorities and progress to team on a continuing basis.
• Ensure that employees have the tools needed to perform their jobs.
• Facilitate communication between management and non-management.
• Facilitate team meetings to discuss progress, initiatives, and/or other matters.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.
• Investigate deviations.
• Lead training on all document modifications prior to effective date.
• Provide leadership, development, and mentoring for others.
• Assist with coordinating activities of support groups.
• Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
• Close out deviations, CAPAs, and/or pAFCAs as needed.
• Identify temporary and permanent fixes to address issues.
• Monitor records to ensure compliance with regulatory requirements.
• Monitor training of employees to ensure compliance.
• Coordinate with representatives from other departments.
• Alert others (for example: supervisor, manager) when problems occur outside of SOPs (Standard Operating Procedures).
• Attend team meetings to discuss progress, initiatives, and/or other matters.
• Collect, record, and report metrics.
• Monitor equipment and/or systems for performance and problem indicators.
• Perform data entry.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Check batch records for accuracy and communicate any issues to necessary parties.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
• Ensure that others carry out laboratory duties in a manner consistent with cGMP.
• Ensure that outgoing product is reviewed, documented, and releasable.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Maintain archived records and documentation.
• Perform logbook reviews.
• Provide feedback on service and quality issues on a timely basis.
• Review and approve quality documentation.
• Serve as SME (subject matter expert) for aseptic operations.
• Fill in for immediate supervisor when absent.
• Lead process improvement activities and teams to meet strategic goals.
• Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
• Develop lean processes and procedures.
• Interact with regulatory agency personnel during audits and inspections.
• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Review and approve documentation needed for qualification of equipment and processes.
• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.
• Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
• Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments.
• Interact with other departments to implement corrective/preventative actions.
• Participate in cross-functional teams to meet strategic goals.
• Review and approve OCMs, change controls, and document revisions.
• Provide "off shift" support (for example: night shift support if you normally work day shift).
• Assess and implement improvements in productivity, waste generation, quality and cost.
• Assign work tasks and activities to others.
• Lead committees or groups of employees tasked with accomplishing some objective(s).
• Coordinate qualification activities.
• Lead change control activities.
• Lead teams in root cause analysis sessions.
• Perform routine sampling activities.
• Performing high purity water testing.
• Provide 24/7 "on-call" support to others.
• Recommend compliance resolutions to management.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com or 844-463-6178.
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