Microbiologist I, 1st Shift

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!

The Microbiologist I 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
• Performs microbiological testing on water, bulk pharmaceutical chemicals, drug products and components, finished products
• Perform method suitability testing on finished products using traditional methods according to procedures. Able to document results and report appropriately
• Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components
• Analyze and read microbiological test results while ensuring proper data integrity and GLP/GMP principles are followed
• Perform growth promotion testing for purchased and prepared media
• Samples raw materials and/or finished products for microbial testing
• Prepare laboratory investigation reports, excursions and/or non- conformance evaluation
• 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)
• 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 general mathematics (addition/subtraction/multiplication/division, dilutions, proportions, percentages)
• Utilize and understand computer applications and programs (Word, Excel, Office 365, LIMS)

PERFORMANCE MEASUREMENTS

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

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelors degree in Biology or related science from an accredited college or university

REQUIRED KNOWLEDGE:

• Ability to read, write and speak English
• Read and comprehend Company policies and procedures, including safety rules and regulations

EXPERIENCE REQUIRED:

• A minimum of 1-2 years of related laboratory work experience in a pharmaceutical environment, or an equivalent combination of training and experience

SKILLS/ABILITIES:

• Ability to multi-task and have good time management skills
• Must have good communication and customer service skills
• Some experience with environmental monitoring and USP 60, 61 & 62

WORKING CONDITIONS

• Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 30 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 tools and equipment
• Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc)

SALARY RANGE

• $50,000 - $58,000, plus bonus

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

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)

Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options.