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 medi

　　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:

　　Bachelor’s degree in Biology, Microbiology , Chemistry or related science from an accredited college or universityREQUIRED 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 science

　　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

　　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)

　　SALARY RANGE

　　$60,000 - $70,000 annuallyBENEFITS

　　PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

　　Medical, behavioral & prescription drug coverage

　　Health Savings Account (HSA)

　　Dental

　　Vision

　　401(k) savings plan with company match and profit sharing

　　Basic and supplemental Life and AD&D insurance

　　Flexible Spending Accounts (FSAs)

　　Short & long-term disability

　　Employee Assistance Program (EAP)

　　Health Advocacy Program

　　PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

　　At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

　　#LI-PDI

　　#LI-ONSITE

　　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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)