Assists supervision in expediting results, Samples final products for the micro count test. Monitor external regulatory trends that have the potential to impact product preservation, In collaboration with stakeholders in R&D and manufacturing, provide technical input to project teams on microbiological issues throughout the project lifecycle, Ensure that state of the art microbiological test methods are employed in the CH organization, with the goal of continual improvement of effectiveness and efficiency, Ensure application of robust and valid scientific approaches to all work conducted in internal and external laboratory networks. Room pressures) and completion of appropriate logs as required by the Manager, 14 Interacts with value stream management on matters related to operational and product microbiological quality. MS Word, MS Excel, e-mail), Must understand basic lab safety, bio-hazard and chemical waste disposal practices, Ability & Flexibility to work a rotational schedule to support a 24/7 plant facility operation, Team Building/Relationship Building - Develops relationships with people throughout the facility and demonstrate team work, Diploma /Bachelor of Science (Microbiology /Chemistry) or related field or equivalent, Fresh Degree /Diploma with Min 3 years or, Degree with Min 3 years /Diploma with Min 6 years, Technical knowledge on lab equipments/ system/ software/ validations, Annual Leave for non-federal service authorized: May Be Authorized, Time in grade (TIG) must be met within 30 days of the closing date of the announcement, Ability to gain the trust of others by taking responsibility for own actions and telling the truth, Knowledge of principles and techniques related to the analysis, presentation and exchange of data, Ability to commit to satisfying internal and external customers, Travel, transportation, and moving expenses will be paid: No, Current or Former Political Appointees: Agencies must seek prior approval from the Office of Personnel Management (OPM) before they can appoint a current or recent political appointee to a competitive or non-political excepted service position at any level under the provisions of title 5, United States Code. Specialist areas include: 1. medicine 2. healthcare 3. research 4. agriculture and food safety 5. environment and climate change. Download the Microbiologist Resume Cover Letter Template for Free. Conduct analysis for microbial limits, assay, microbial identification, environmental monitoring, etc, Calibrates equipment as required, in accordance with set methods and procedures, Reports malfunctioning equipment to Laboratory Supervisors or deputies for repair, Alerts Laboratory Supervisors or deputies verbally in the event of any result not meeting Impax specification or of any questionable results generated, Ensures adequate stocking of Laboratory reagents and consumables, through monitoring re-order levels and timely notification to Laboratory Supervisors or deputies, Records expiry dates of analytical reagents developed in-house by noting the expiry date on container or document, Handles and disposes dangerous materials, such as pathogen, arsenic, cyanide, and concentrated acids, in accordance with standard safety practices, Records regulated toxic controlled chemicals usage and disposition in accordance with standard predetermined procedures, Maintains neatness of laboratory that following the concept of 6S – Sort, Set in order, Shine, Standardize, Sustain, Safety, Supports investigative testing and investigation activities, Perform in a continuous improvement attitude to meet the predetermined KPI, Follows the training program schedule to complete the directed training courses, Performs certification activities in accordance with regulatory and industry requirements like granted license for operating autoclave, Completes delegated tasks by the agreed completion date and treat as commitment, Attends weekly laboratory meetings or delegated meetings, Other duties as assigned by the supervisors or company, B.S. Experience in quality control / quality assurance in a medical (animal health, Completes daily assigned routine tasks timely and accurately (may include collection and/or testing of GMP samples, reporting of data, general lab housekeeping), Paperwork review, data entry, filing, etc, Serves on team projects in the role of testing support, as needed, Effectively communicates issues/hurdles to team lead and/or manager, Maintains requirements for ISO 17025 (International Organization for Standardization, global quality standard for testing and calibration laboratories), Develops, documents, updates, and maintains Lab SOPs and approved procedures, Identifies and evaluates new methods for detecting, enumerating and identifying microorganisms of concern, Generates monthly reports describing laboratory activities, trends, learnings and expenditures, Maintains and calibrates laboratory equipment as well as a clean laboratory work environment, Performs other assorted duties related to quality assurance, research, and laboratory operations as assigned, BS Degree with major studies in Biology, Microbiology, Food Science or Biochemistry required. standard work, level loading, test method execution, documentation updates and equipment qualification etc, Supports Team leader on day to day testing operations, Bioburden, Endotoxin, Sterility Testing and Microbial Identification using genetic methods. ... CV vs. Resume: The Difference. HelpBU and bottlers on micro test protocol design. Knowledge of GMP, ISO standards, and regulatory/corporate requirements is an asset, Effective analytical and problem solving skills and critical thinking abilities, Communication skills, ability to work with all levels of the organization, Ability to balance multiple priorities with excellent time management skills, Detail oriented with the ability to work under pressure, Ability to work off shift, holidays and plant shut downs on a rotating basis, Coverage for production overtime Saturdays on a rotating basis is mandatory, Must comply with Good Laboratory Practices, When performing Sterilizer Quals: the work is conducted in extreme environmental conditions (temperature, humidity, wet, moving trucks, loud, hot pipes), Experience in a lab or manufacturing environment, Previous experience working in a Quality function, Strong analytical and problem solving skills and critical thinking abilities, Strong communication skills, ability to work with all levels of the organization, Execute testing related to the monitoring program of controlled environments of the Costa Rica site, Contribute as matter expert on biocompatibility, sterilization and microbiology, assuring the product meets documented requirements and that processes are controlled, Perform or participate in the validation of the Microbiology Lab�s new equipment, Contribute to maintenance of the Sterilization Dosage audit program, Coordinate the steps in order to perform Bio burden and LAL program tests on finished goods, Execute testing related to the monitoring program of water systems of the Costa Rica site, Perform the inspection of cultures received in the site, Assure proper supply of reagents and materials required for lab operation, Support tasks related to microbiology investigation systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system, Support the decontamination of product contaminated with bio-infectious material, received as part of the customer complaint process, Act as Quality Engineer for Facilities related matters, Establish and maintain Microbiology labs in full cGMP-compliance, Install lab equipment and performs qualification and validation activities of lab equipment following written protocols, Provide guidance and support activities to run and validate necessary test methods or compendia methods in the lab and performs routine performs testing under cGMP, Responsible for planning and generating method validation documentation and implement method in cGMP operations, Provide guidance for procedure and method development (test method/assays) and ensure specific procedures are implemented to perform testing following routine activities, Reviews QA/QC documents to ensure completeness, accuracy, consistency and clarity and materials or final products have been manufactured, tested or inspected according to specification and cGMPs, Be the on-site technical expert for sterilization validations, controlled environments, routine microbial monitoring requirements, product release testing, providing direction for manufacturing for modifications to controlled environments and facility auxiliaries and determine requirements for environmental testing. 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