Microbiologist II

PDI; New York (NY); On-site; USD 60,000 - 70,000; Full time

Job summary

An established industry player is seeking a Microbiologist II to join their dynamic Quality Control team. This role focuses on performing microbiological testing and analysis to ensure product safety and compliance with regulatory standards. You'll be responsible for conducting routine tests, maintaining laboratory equipment, and training technicians. This is an exciting opportunity to contribute to innovative health solutions while working in a supportive environment that values research and quality. Join a forward-thinking company that offers a comprehensive benefits package and fosters a healthy work/life balance.

Benefits

Health Savings Account (HSA)

401(k) with company match

Flexible Spending Accounts (FSAs)

Short & long-term disability

Paid parental leave

Employee Assistance Program (EAP)

Paid time off programs

Summer hours

Legal services

Employee discounts

Qualifications

• 2-4 years of experience in pharmaceutical microbiology or equivalent training.
• Proficiency in microbiological testing and analysis.

Responsibilities

• Conduct microbiological testing and analysis of products and raw materials.
• Ensure compliance with Good Manufacturing Practices (cGMP).

Skills

Microbiology Techniques

Data Integrity Principles

Communication Skills

Time Management

Aseptic Techniques

Education

Bachelor’s degree in Biology

Bachelor’s degree in Microbiology

Bachelor’s degree in Chemistry

Tools

Laboratory Equipment

LIMS

Job description

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Talent Acquisition Specialist @ PDI | SHRM-CP

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.

*Please note: PDI does not provide sponsorship for employment visas*

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:

1. 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.
2. Perform method suitability testing on finished products using traditional methods according to procedures. Able to document results and report appropriately.
3. Sampling and testing water, environmental air and surface. Able to report, analyze, and trend data.
4. Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes.
5. Perform basic identification of microorganisms.
6. Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components.
7. Perform growth promotion testing for purchased and prepared media.
8. Samples raw materials and/or finished products for microbial testing aseptically.
9. Assist in the maintenance and calibration and/or certifications of laboratory equipment.
10. Train and qualify technicians and/or microbiologists on testing procedures and techniques, as well as oversee data generated into electronic or laboratory notebooks.
11. Perform review of generated data by microbiologists in a timely manner and ensure ALCOA principles are applied.
12. Collaborate with third party lab to ensure specifications and results are provided and processed appropriately.
13. Support LIMS or special projects specifically related to microbiology.
14. Able to write scientifically sound microbiology investigation reports, non-conformance evaluation and root cause investigations.
15. Write or update Standard Operating Procedures (SOPs) current to ensure compliance to regulatory standards.
16. Ensures that lab activities maintain compliance with current Good Manufacturing Procedures (cGMP), cleanliness and data integrity requirements at all times.
17. Prepares samples for shipment to external contract laboratory for microbiological testing.
18. Performs additional activities as assigned.

PERFORMANCE MEASUREMENTS

1. Annual Goals and Objectives.
2. Qualification for performing test methods.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

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

REQUIRED KNOWLEDGE:

1. Understand Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA).
2. Traditional microbiology techniques (i.e. gram staining, streak plating, culture maintenance and aseptic techniques).
3. Knowledge of USP chapters related to microbiology is a plus.

EXPERIENCE REQUIRED:

1. A minimum of 2-4 years of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.

SKILLS/ABILITIES:

1. Proficiency in reading, writing and speaking English.
2. Be able to read and comprehend Company policies and procedures, including safety rules and regulations.
3. Ability to multi-task and have good time management skills.
4. Must have good communication and customer service skills.

WORKING CONDITIONS:

1. 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.
2. Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment.
3. Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc).

SALARY RANGE:

1. $60,000 - $70,000 annually, plus bonus.

BENEFITS:

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

1. Health Savings Account (HSA).
2. Vision.
3. 401(k) savings plan with company match and profit sharing.
4. Basic and supplemental Life and AD&D insurance.
5. Flexible Spending Accounts (FSAs).
6. Short & long-term disability.
7. Employee Assistance Program (EAP).
8. 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.

Seniority level

Associate

Employment type

Full-time

Job function

Science and Quality Assurance

Industries: Manufacturing, Pharmaceutical Manufacturing, and Medical Device.