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

•The schedule for this position is Monday-Friday, 12:00 pm - 8:30 pm

• 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.

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

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

Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (PPE) (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

$45,000 - $48,000 annually, plus bonus and overtime pay as necessary PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: Medical & prescription drug coverage Dental / Vision plan 401(k) savings plan with company match Basic and supplemental life insurance Flexible Spending Accounts (FSAs) Short- and long-term disability benefits Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans and perks such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance, tuition assistance, referral bonus program, paid parental leave, a health club rebate program and more At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options #LI-BK1 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.