QA Microbiologist II

PDI; Orangeburg (NY); On-site; USD 60,000 - 68,000; Full time

Benefits offered by this job

Medical insurance

Health Savings Account

Dental care

Vision care

401(k) with match

Life and AD&D insurance

FSAs

Disability insurance

Paid time off

Job summary

PDI is seeking a Microbiologist II to join the Quality Control team. The role focuses on performing routine microbiological testing of water, raw materials, drug products, and finished products.

You will document results, ensure ALCOA data integrity, and support both internal and third-party labs. Qualified candidates have at least 3 years in pharmaceutical microbiology, a biology-related bachelor's degree, and strong knowledge of cGMP and FDA guidelines.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry or related science required.
• Proficiency in reading, writing, and speaking English.
• Understanding cGMP and FDA guidelines.
• Experience in pharmaceutical microbiology preferred.

Responsibilities

• Perform routine microbiological testing for water, chemicals, drug products and finished products.
• Document results and report per procedures; ensure data integrity (ALCOA).
• Prepare media for microbiological testing; perform growth promotion testing.
• Conduct aseptic sampling and calibrate/maintain lab equipment.
• Train technicians and microbiologists on testing procedures and data handling.
• Collaborate with external labs and support LIMS projects.

Skills

English proficiency

Time management

Communication

Safety compliance

Education

Bachelor's degree in Biology, Microbiology, Chemistry or related science

Tools

LIMS

Pipettes

Incubators

Job 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

*The hours for this role are Mon-Fri, 12:00 pm - 8:30 pm* 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

The Microbiologist II is responsible for performing microbiological testing, analysis, and ensure results are appropriately processed with data integrity principles, in accordance with internal procedures and methods.

TESTING & ANALYSIS:

• Conduct routine testing for water, bulk pharmaceutical chemicals, drug products, and finished products. Provide assessment of results according to appropriate test methods and work instructions
• Perform method suitability testing on finished products using traditional methods according to procedures. Able to document results and report appropriately
• Sampling and testing water, environmental air and surface. Able to report, analyze, and trend data.
• Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes
• Perform basic identification of microorganisms
• 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 aseptically
• Assist in the maintenance and calibration and/or certifications of laboratory equipment
• Train and qualify technicians and/or microbiologists on testing procedures and techniques, as well as oversee data generated into electronic or laboratory notebooks
• Perform review of generated data by microbiologists in a timely manner and ensure ALCOA principles are applied
• Collaborate with third party lab to ensure specifications and results are provided and processed appropriately
• Support LIMS or special projects specifically related to microbiology
• Able to write scientifically sound microbiology investigation reports, non- conformance evaluation and root cause investigations
• Write or update Standard Operating Procedures (SOPS) current to ensure compliance to regulatory standards
• Ensures that lab activities maintain compliance with current Good Manufacturing Procedures (cGMP), cleanliness and data integrity requirements at all times
• Prepares samples for shipment to external contract laboratory for microbiological testing
• Performs additional activities as assigned

PERFORMANCE MEASUREMENTS

• Annual Goals and Objectives
• 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 university

REQUIRED KNOWLEDGE:

• Understand Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA)
• Traditional microbiology techniques (i.e. gram staining, streak plating, culture maintenance and aseptic techniques)
• Knowledge of USP chapters related to microbiology (<60>, <61>, <62>)

EXPERIENCE REQUIRED:

• A minimum of 3 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)

Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship.

SALARY RANGE:

• $60,000 - $68,000 annually, plus bonus

BENEFITS:

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

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 and paid parental leave

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 notice from the Department of Labor.