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 three 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.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Prepares media, diluents, and reagent solutions, maintains appropriate sample testing documentation, and provides lead direction and training to more junior level staff and performs advanced technical duties.
TESTING & ANALYSIS:
While the day-to-day duties of a microbiology technician is determined by their employer, there are many core tasks associated with the role. Based on our analysis of job listings, these may include:
- Collects purified water samples from various USP Purified Water Loops used to manufacture or test drug products
- Performs microbiological testing on water, bulk pharmaceutical chemicals, and components
- Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes
- Perform environmental monitoring of the laboratory and production areas
- Analyze and read microbiological test results while ensuring proper data integrity and GLP/GMP principles are followed
- Prepares media, diluents and reagent solutions used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components.
- Perform growth promotion testing for purchased and prepared media
- Writes lab excursions under general supervision
- Maintain stock bacteria cultures used for testing
- Maintain the cleanliness and organization of the laboratory
- Receive laboratory supplies and chemicals and maintains stock and inventory control.
- Assist in the maintenance and calibration and/or certifications of laboratory equipment
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- 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
- Utilize and understand computer applications and programs (Word, Excel, Power Point, Office 365, LIMS, BPCS)
PERFORMANCE MEASUREMENTS
- Annual Goals and Objectives
- Right first time Metrics
- Training documentation
- Qualification for performing tests
QUALIFICATIONS
EDUCATION/CERTIFICATION:
- Bachelor’s Degree (preferred) in Biology, Microbiology, Chemistry or related science from an accredited college
REQUIRED KNOWLEDGE:
- General knowledge of Laboratory instruments; pH, balance, microscope Autoclave and good laboratory techniques (recommended)
- Mathematics and statistics skills
EXPERIENCE REQUIRED:
- A minimum of 0-1 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
PHYSICAL REQUIREMENTS:
- Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 40 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 (PPE) (e.g. respirators, gloves, etc)
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)