QA Microbiologist II

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 Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

About the role

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.

Responsibilities

• Perform microbiological testing, analysis, and ensure results are appropriately processed with data integrity principles, in accordance with internal procedures and methods.
• 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.
• Document results and report appropriately.
• Sample and test water, environmental air and surfaces; report, analyze, and trend data.
• Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes.
• Perform basic identification of microorganisms.
• Prepare media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components.
• Perform growth promotion testing for purchased and prepared media.
• Sample raw materials and/or finished products for microbial testing aseptically.
• Assist in the maintenance, 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.
• Write scientifically sound microbiology investigation reports, non-conformance evaluation and root cause investigations.
• Write or update Standard Operating Procedures (SOPs) to ensure compliance to regulatory standards.
• Ensure that lab activities maintain compliance with current Good Manufacturing Procedures (cGMP), cleanliness and data integrity requirements at all times.
• Prepare samples for shipment to external contract laboratory for microbiological testing.
• Perform additional activities as assigned.

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry or related science from an accredited college or university.
• Understand Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA).
• Knowledge of traditional microbiology techniques (i.e. gram staining, streak plating, culture maintenance and aseptic techniques).
• Knowledge of USP chapters related to microbiology.
• A minimum of 3 years of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.
• Proficiency in reading, writing and speaking English.
• Ability to read and comprehend Company policies and procedures, including safety rules and regulations.
• Ability to multi-task and have good time management skills.
• Good communication and customer service skills.

Working Conditions

• Subject to extended periods of sitting, standing, walking, lifting materials weighing up to 50 pounds, vision to monitor and moderate to loud noise levels.
• May be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment.
• Work is performed in a laboratory environment.
• Must be able to use personal protective equipment (e.g. respirators, gloves, etc).

Pay

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

Schedule

Monday to Friday, 12:00 pm - 8:30 pm.

Benefits

• 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.
• Paid time off programs including: sick & safe leave, vacation, company & floating holidays and paid parental leave.
• Voluntary benefits such as: legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.