Archivist/Document Coordinator

Frontage Laboratories

Posted 3 months ago

Full Time

Exton, Pennsylvania

In Person

Smart Summary

Responsibilities

The role involves controlling, maintaining, and archiving regulated documents for the Bioanalytical group. Responsibilities include performing quality checks on hard copy data and updating electronic databases in accordance with 21 CFR part 58.190.

Qualifications

You have a High School diploma and experience in archiving, with strong communication, attention to detail, and organizational skills. You will support the Bio Analytical group by maintaining a secure controlled document management system, ensuring documents are controlled from inception to archiving in an organized and timely fashion.

Must Have Skills for ATS

21 CFR part 58.190

document management system

Job Description

                                                                                        Archivist/Document Coordinator

Full-Time
Exton


Frontage Laboratories: 

Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

BioAnalytical:

At Frontage, we believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex drug development challenges. Our deep scientific expertise in method development, transfer and validation allows us to provide clients with complex solutions for challenging studies including oncology clinical trials, rare disease assay development and specialty assays. 

Position Summary:

The Associate Archivist supports BIO Analytical. Position involves controlling, maintaining and archiving regulated documents for the Bio analytical group. The focus of the role is to support archivist in maintaining a secure controlled document management system. This will entail working across the Bio analytical group to ensure documents are controlled from inception to archived in an organized timely fashion.

Job Responsibilities:

  • Follows 21 CFR part 58.190 and any applicable guidelines and SOPs.
  • Assists Archivist with archiving of hard copy data (includes but is not limited to Quality Check of the data package, filing in archive, and updating all electronic data bases.
  • Reviews and does a quality check on the hard copies prior to archiving

Requirements: 

  • High School diploma, or higher, with Archiving experience as a plus.
  • Excellent communication, attention to detail and organizational skills.

Salary and Benefits:

Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Frontage Laboratories

Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004. As an FDA-registered and inspected global pharmaceutical development and manufacturing organization, Frontage is headquartered in Exton, PA, with a state-of-the-art 26 facilities spread across Pennsylvania, New Jersey, Illinois, Ohio, California, Florida, Canada, Italy, and China. We are dedicated to accelerating the development of innovative therapies by providing a broad range of science-driven and quality-focused services including drug discovery, DMPK, preclinical safety & toxicology, formulation development and manufacturing, analytical, clinical trials, bioanalytical, and central labs. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the US, EU, China, and other countries.
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