Sampling Technician Job Trenton area,New Jersey USA,Quality Assurance

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

High School diploma.
3+ years applicable industry experience in pharmaceutical or chemical industry preferred.
Knowledge/

Skills:
Ability to multi-task, work cross functionally and demonstrate diplomatic skills
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
Ability to effectively present information and respond to questions from peers, management, suppliers and customers
Strong organizational skills
Experience with GMP and ICH Regulations with emphasis on data integrity
Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access)
Ability to work effectively under pressure to meet deadlines.
Physical Requirements:
Mathematical and reasoning ability
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
Ability to work effectively under pressure for self and the department.
An individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Be accessible to the laboratory and plant area(s) and office staff and to use required office equipment.
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 the…