Title: QC Microbiology Scientist
Duration: 6 months contract (Temp to Hire)
In office M-F Hours 8-5 with 1 weekend per month rotation working Sat and Sunday a few hours each day in the morning.
Job Summary:
- Ensures that microbiological quality standards are consistently met, and product integrity is maintained for susceptible materials, component parts, equipment, facilities and other items which affect product manufacturing systems and processes.
- Supports departmental goals by coordinating and / or performing lab activities to ensure timely support for supply chain needs and /or meeting project deadlines.
- Partners with operations and other quality groups to ensure microbiological risk consideration in facility, equipment, and system design and implementation.
- Applies technical knowledge globally in collaborative response to microbial contamination issues, aberrant test results, environmental excursions, systems development and validation, and root cause analysis
Experience:
- Experience: 3+ years Supervisory Experience: Field of Experience
- Education: Bachelor/University Degree Education Focus: Bachelor’s degree in Microbiology or Biology or equivalent with a minimum of 3 years related work experience or an Associate degree (or 16 hrs. college level science courses) and 6 years experience in laboratory environment
Responsibilities:
- Core duties and responsibilities may be generally aligned with either Quality Control Testing activities or Environmental Monitoring and Cleaning Validation processes however cross functional awareness is expected and some tasks may have cross functional relevance and application.
- Job requirements may include activities from both core areas.
- Common responsibilities include the ability to recognize contamination potential and inconsistent or out-of-specification results or trends.
- Responsible for timely communication as appropriate to customer groups and Quality management in the event of aberrant test results which may delay or prohibit an item’s release.
- Responsible for ensuring all quantities of affected materials or items are accounted for and appropriately locked or held to prevent use or sale until compliance is determined.
- Ensures timely response to Global Inventory and Supply Chain business needs including verbal and written communications and timely disposition of approved materials. Interfaces with R&D Microbiology, other quality groups, and production operations regarding rework scenarios, water damage, and problem resolution.
Quality Control core duties and responsibilities:
- Coordinates and provides support for daily activities in the Quality Control Microbiology lab including Microbial Content Testing, Rapid Method Tests, Media Preparation, and all related tasks.
- Provides technical support for advanced skills.
- Responsible for timely testing of all raw materials, process water, bulk products, finished products, and components that require Micro testing.
- Monitors reporting systems to ensure appropriate disposition timing, observe for missed samples, and for incomplete data.
- Performs GMP review and approval of all QC Micro sample data and media / supply production records assuring all data and records are complete and accurate.
- Serves as an interface with customer groups and contract & raw material vendors to facilitate reporting of test results and to resolve concerns over Microbial Content Test specification requirements or test procedures.
- Researches, performs, and documents validation support studies following defined procedures.
- Performs non-standard testing and analysis to respond to identified microbial quality needs.
- Evaluates and validates current microbiological methods, procedures, and practices to ensure effectiveness and compliance. Uses thorough foundation in microbiological principles to collaborate in the development of new processes, methods, and technology.
- Approves item specifications to ensure appropriate microbial
Environmental Monitoring core duties and responsibilities:
- Supports the Micro Environmental Audit program and executes environmental audit processes and facility inspections.
- Supports contamination investigations by gathering crucial equipment, material, batch, and test documentation and / or performing critical control point testing.
- Coordinates and performs Cleaning Validation studies and participates in internal System Audits of Client Inc. manufacturing operations.
- Supports global cleaning validation and micro risk evaluation efforts.
- Participates on global facilities, engineering, quality, and product or equipment related project teams to ensure Microbial Quality standards and concerns are considered from design through implementation.
- Interfaces with Operations and Quality groups regarding equipment or product / process issues, GMP and Micro risk issues, sanitation status, water deviations, Micro concerns, and near-miss issues.
- Applies knowledge and understanding of RO Water system and USP water standards to help ensure micro integrity of the RO Process Water System.
- Appropriately documents all data and results; Performs data trend analysis; Assists in preparation of SOP’s, methods, etc. as required.
- Reviews Operations SOP’s, OPL’s, WI’s, etc. for acceptable compliance to Micro standards.
- Possesses matured microbiological judgment to recognize microbial quality risk as well as inconsistent, concerning, or failing results or trends and serves as a knowledgeable professional for facility, process, and equipment systems relative to micro risk potential.
Participates on internal audit teams as needed:
- Provides technical support for advanced microbiological skills. Performs diversified and complex microbiological tasks as needed.
- Applies knowledge and thorough understanding of microbiological method principles, systems, and guidelines. Ensures accurate, timely documentation of all data and test results.
- Provides technical expertise as needed globally for out-of-spec investigations, environmental excursions, and other microbial contamination issues.
- Works to identify root cause through use of Micro Contamination Checklists, CAPA, and partnership with technical experts, as necessary.
May supervise, lead, and train non-exempt technicians or Assistant Scientists:
- Manages or oversees laboratory supply purchases and equipment maintenance; Provides input to budget processes.
- Performs miscellaneous laboratory duties such as general cleaning, supply management, and waste management.
- Performs and documents departmental training, intra-departmental cross-training, micro-orientation training, micro hygiene awareness training, laboratory safety training, and other Micro / GMP related training as needed.
