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Microbiologist II - 1st Shift

Employer
Nice Pak
Location
Orangeburg, New York, US
Salary
Competitive
Closing date
May 19, 2022

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Sector
Academic / Research
Field
Conservation science
Discipline
Statistics
Salary Type
Salary
Employment Type
Full time
Description

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

Part of the Quality Control department that evaluates raw materials, other supplies and the finished, packaged product and ensures compliance to Good Manufacturing Practices. Provides support to the operations and manufacturing departments to ensure safe and effective finished product release.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Conducts routine microbiological testing and analysis for water; bulk pharmaceutical chemicals and drug products; collects samples; prepares standards/controls, media and sample solutions; and maintains appropriate records.

TESTING & ANALYSIS:
  • Collects purified water samples from the various USP Purified Water Loops used to manufacture or test drug products
  • Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components
  • Perform growth promotion testing for purchased and prepared media
  • Samples raw materials and/or finished products for microbial testing
  • Performs microbiological testing on water, bulk pharmaceutical chemicals, drug products and components, finished products
  • Collects environmental samples for microbiological analysis
  • Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes
  • Perform basic identification of microorganisms (Gram stain, Selective Media, confirmatory tests)
  • Assist in the maintenance and calibration and/or certifications of laboratory equipment
  • Maintain the cleanliness and organization of the laboratory
  • Prepares samples for shipment to outside contract laboratory for microbiological testing
  • Performs related support activities and duties as assigned.

    TECHNICAL:
  • Follow all Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements
  • Perform laboratory tasks using general microbiological laboratory techniques and procedures
  • Follow internal sampling methods and quality control systems
  • Perform basic mathematics (addition/subtraction/multiplication/division, dilutions, proportions, percentages)
  • Utilize and understand computer applications and programs (Word, Excel, Power Point, Office 365, LIMS, BPCS)

PERFORMANCE MEASUREMENTS
  • Annual Goals and Objectives
  • Right first time Metrics
  • Training documentation
  • Qualification for performing test methods

QUALIFICATIONS

EDUCATION/CERTIFICATION:
  • Bachelors degree in Biology, Microbiology , Chemistry or related science from an accredited college or university

REQUIRED KNOWLEDGE:
  • Understand Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA)
  • Classical microbiology techniques (i.e. gram staining, streak plating, culture maintenance and aseptic techniques)
  • Microscopy, autoclave and biological and laminar flow hood usage
  • Mathematics and statistics
  • Microbiology or related sciences
  • Microbial sample preparation techniques

EXPERIENCE REQUIRED:
  • A minimum of 2-4 year of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.

SKILLS/ABILITIES:
  • Proficiency in reading, writing and speaking English
  • Be able to read and comprehend Company policies and procedures, including safety rules and regulations
  • Ability to multi-task and have good time management skills.
  • Must have good communication and customer service skills.

WORKING CONDITIONS

PHYSICAL REQUIREMENTS:
  • Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 50 pounds, vision to monitor and moderate to loud noise levels.
  • Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tolls and equipment.
  • Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

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