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:
- Knowledge of microbiological principles, aseptic techniques, and common laboratory practices
- Working understanding of cGMP, GLP, FDA regulatory requirements, and quality control systems in a pharmaceutical or regulated manufacturing environment.
- Familiarity with microbiological test methods such as bioburden testing, microbial limits testing, environmental monitoring, growth promotion, method suitability, and water system testing
- Ability to read, write, and communicate clearly in English
- Ability to read and comprehend standard operating procedures (SOPs), safety guidelines, and Company policies.
EXPERIENCE REQUIRED:
- 6 months - 1 year of hands-on microbiology laboratory experience in a pharmaceutical, medical device, or similarly regulated industry, or an equivalent combination of training and experience.
- Experience performing routine microbiological analyses, aqueous sampling, environmental monitoring, and preparing media, reagents, and controls.
- Experience documenting work in compliance with data integrity principles and preparing laboratory records, deviations, or investigation reports.
SKILLS/ABILITIES:
- Proficient in general microbiological laboratory techniques including aseptic sampling, plate handling, streaking, gram staining, and microorganism enumeration.
- Strong analytical and observational skills, with the ability to accurately read, interpret, and record microbiological results.
- Ability to perform basic laboratory mathematics (dilutions, conversions, percentages, proportions).
- Competency using computer applications such as LIMS, Microsoft Office (Word, Excel, Outlook), and electronic documentation systems.
- Strong organizational skills with the ability to prioritize multiple tasks and manage time effectively in a fast-paced environment.
- Excellent communication skills and the ability to work collaboratively with cross-functional teams.
- Ability to maintain a clean, safe, and compliant laboratory workspace.
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
- $55,000 - $60,000 annually, 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.
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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
