Process Development Technician

Process Development Technician

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

• The incumbent will prepare analytical, formulation, stability, manufacturing, operating procedures and other technical and GMP related documentation.

• Use Electronic Document Management System (EDMS) for the preparation and maintenance of electronic (documents) records.

• Administer the electronic document review and approval process.

• All work is to be done in a compliant manner according to SOP guidelines and cGMPs.

• The incumbent will review for accuracy, readability and format ensuring that all documents are in compliance with company policies/guidelines and meet the required timelines.

• This position will also maintain hard copy files, electronic data, and records for Consumer Global R&D and enter data in electronic database for data tracking purposes in support of Training department.

• Responsible for performing essential functions of record operations, such as indexing, filing, retrieving, distributing (via copying or check-out), and ensuring the integrity of records housed in the PR&D site repository.

• The individual also participates in various operations, such as annual file review, relocation of records, inventory control, etc., as required.

• The individual assists with other QC&C clerical activities, as required

Qualifications

• Position requires excellent writing, communication, and organizational skills, and attention to detail.

• Technical writing experience in the pharmaceutical industry is preferred.

• Advanced knowledge of Microsoft tool suite (Word, Excel, PowerPoint, and Access) is required.

• BS Degree in Scientific field plus 1-3 years of direct experience preferred (Pharmaceutical experience a plus).