Microbiology Technician

PDI•Orangeburg, NY

6d•Onsite

About The Position

Part of the Quality Assurance department; 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.

Requirements

Bachelor’s Degree (preferred) in Biology, Microbiology, Chemistry or related science from an accredited college
General knowledge of Laboratory instruments; pH, balance, microscope
Autoclave and good laboratory techniques (recommended)
Mathematics and statistics skills
A minimum of 0-1 year of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.
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.

Responsibilities

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.
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.
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)