Sampling Technician, Clean Room -2nd Shift Monday-Fri

Job Title: Sampling Technician, Clean Room

Location: Columbus

Job Type: Ful time

Req :9458

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sampling Technician, Clean Room to join our team. In this role, you will be responsible for ensuring quality and compliance with government regulations and Hikma standards with respect to inspecting buy-in drug products, incoming raw materials and packaging components utilized in the production and research of pharmaceutical products.

All incoming materials are inspected for compliance with procedural specifications. Additionally, all raw materials and packaging components are properly sampled in a cGMP environment in order to facilitate the Quality Control (QC) laboratory required analysis for release into production.

Key Responsibilities:

• Visually inspects all incoming vendor labels, containers, documentation, packaging and raw materials.
• Sorts out any damages according to strict Work Instructions (WI’s) and Standard Operating Procedures (SOP’s) Specifications. Records any irregularities noted and reports them to the Coach as well as Purchasing, Transportation and Customs Compliance and Finance when required.
• Coach as well as Purchasing, Transportation and Customs Compliance and Finance when required.
• Visually inspects one batch of each product lot based on ANSI statistical sampling charts per work instructions or special requests. Uses Raman device to perform basic testing. Documents and reports
• Maintains sampling area to meet FDA regulatory requirements. Restocks sampling materials from component store. Cleans and sanitizes rooms per SOP and WI's. Verifies and maintains daily logs (cleaning log and scale verification log) and calibrations of equipment used for sampling. results to QCSM.
• Completes documentation related to inspections and sampling activity (cleaning logs, sampling weights accurately recorded, temperature monitors, visual inspection worksheets, capsule worksheets and narcotic records) per SOP's and WI's.
• Actively participates in and completes all Company training programs for WI's, SOP's, Company policies, and safety programs demonstrating learned knowledge on a daily basis. Actively participates in all Company and departmental meetings, Performance Centers, etc.
• Completes other duties as assigned including specified Logistics Technician and Senior Logistics Technician tasks.

Skills:

Performs calculations accurately. Makes suggestions on prioritizing self-work loads or decisions that may have impact on product or customer requirements, seeks guidance from management.

• Operates industrial forklifts in a confined area where pedestrians and equipment share the same work area.
• Utilizes both Radio Frequency (RF) gun and personal computer (PC) for processing and reviewing transactions, looking up specifications requirements and recording data.
• Adjusts to changing workload and moves from one task to another as situations or workloads change.
• Participates in prioritizing and assigning daily tasks by making suggestions to Team Lead or Coach.
• Analyzes issues and implements solutions for intermediate issues (inventory, specifications or informational).
• Communicates with internal customers to resolve issues and establish sampling issues.
• Offers process improvements and develops and implements change.
• Executes daily responsibilities that influence the…