Sampling Technician

About Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Job Overview

Position: Sampling Technician

Department: Quality

Location: Somerset (US)

Ardena is hiring a Sampling Technician to join the Quality team at our Somerset site. The Sampling Technician is responsible for performing the sampling of raw materials for QC release testing and retain samples.

Key Responsibilities

Specific Duties, Activities, and Responsibilities:

· Responsible for the daily operation of the sampling booth.

· Perform sampling of raw materials and active pharmaceutical ingredients.

· Sampling of finished products, as needed.

· Ensure samples are properly labeled.

· Fully qualified and trained to sample potent compounds, as needed.

· Fully qualified and trained to sample DEA Controlled Drug Substances, as needed.

· Review specifications and other documentation prior to performing sampling.

· Assures the sampling booth is maintained in a clean and orderly manner and stocked with appropriate sampling supplies.

· Perform daily calibration of balances.

· Perform inspections and audits of area, as needed.

· Document all work performed in sampling logbooks, cleaning logbooks, balance logbooks and retain sample logbooks.

· Log samples in to SSC and Retain area upon completion of sampling.

· Be cross-trained and proficient in Stability/Sample Coordination tasks and able to work in that area, as needed.

· Be proficient in Quality Systems.

· Assists in annual SOP review and revisions, if deemed necessary.

· Comply with Health, Safety and Environmental responsibilities for the position.

· Other tasks as assigned.

Required Qualifications:

o High School diploma.

o 3+ years applicable industry experience in pharmaceutical or chemical industry preferred.

· Knowledge/Skills:

o Ability to multi-task, work cross functionally and demonstrate diplomatic skills

o Proficient (excellent) in English verbal and written communication skills to convey and receive the ideas and instructions to/from others within and outside the organization

o Ability to effectively present information and respond to questions from peers, management, suppliers and customers

o Strong organizational skills

o Experience with GMP and ICH Regulations with emphasis on data integrity

o Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access)

o Ability to work effectively under pressure to meet deadlines.

· Physical Requirements:

o Mathematical and reasoning ability

o Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form

o Ability to work effectively under pressure to meet deadlines for both self and the department.

o An individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

o Be accessible to the laboratory and plant area(s) and office staff and to use required office equipment.

o Specific vision requirements include reading written documents and use of computer monitor screen.

Work Environment/Safety Conditions:

· Must wear safety glasses, in addition to other specified PPE, in all designated areas.

· Must follow any applicable plant safety requirements.

· Must be fit-tested as per OSHA regulations, trained and capable of wearing air purifying respirator.

· Must be trained in plant hazardous material procedures.

· Must use approved fall prevention devices when performing elevated tasks.

· Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift.

· Working conditions will be Temperature and Humidity controlled as needed for product.

· Individual’s primary work-area is located in the operations area, where the noise level can be moderate to high. Certain operations may require hearing protection.

What Ardena Offers

Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.

Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.

Benefits and perks at Ardena include:

• Competitive salary and tailored benefits package (adjusted per role and location)

• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)

• International and collaborative work environment across European and US sites

• Access to professional development and training programs

• Meaningful work on pharmaceutical development projects that advance patient health

• A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent

Salary Range : $50,000 - $60,000 (based on experience)

How to Apply

Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.