Job Title: Sampling Technician, Clean Room
Location: Columbus
Job Type: Ful time
Req ID: 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 internal Dock to Stock metric.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
High School diploma or GED
OSHA certified industrial truck certification preferred.
Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel) and SAP/ RF is a plus.
Ability to perform timely and accurate computer transactions.
Demonstrated proficiency in interpersonal communication skills – both oral and written.
Ability to work independently with minimal supervision.
Demonstrated problem analysis and problem-solving abilities requiring attention to detail, accuracy, cGMP and scientific judgment.
Demonstrated Quality Awareness.
Attention to detail- must be able to identify errors and potential compliance issues
Knowledge of GMP regulations as they relate to quality control job functions such as sampling and basic physico-chemical testing.
Ability to obtain forklift certification/s for specific work area in order to retrieve and store materials in the storage racks.
Preferred Qualifications:
Four years of warehouse & distribution experience is preferred.
Experience in a cGMP/pharmaceutical environment is preferred.
Experience with computer applications including Microsoft products and an ERP system, such as SAP, preferred.
What We Offer:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.