ProSciento, Inc.

Quality Electronic Document Control Associate

US-CA-San Diego
4 days ago

Overview

Summary: The Quality Assurance Associate reports to the Associate Director, Quality Assurance and is responsible for performing activities pertaining to assuring compliance with GCP/ICH, ISO 9001 and applicable regulatory requirements, and adherence to company policies and procedures. The Quality Assurance Associate’s main responsibilities include administration and maintenance of document management system, assist in the quality audit and CAPA programs, provide quality training, and the maintenance of site delegation logs. Performs duties in accordance with company’s values, policies, and procedures.

 

We are currently considering local candidates only.

 

Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.

Provides support to the quality assurance department through the administration and maintenance of the following quality systems/programs/processes, including but not limited to:  

Electronic Document System (eDMS):

  • Serves as the administrator and subject matter expert for the eDMS.
  • Maintains controlled documents (i.e. Standard Operating Procedures (SOPs), Work Instructions (WIs), Associated Documents).
  • Assigns and tracks document training (read and apply).
  • Monitors, investigates, and troubleshoots issues related to workflows and other eDMS specific, system related processes.
  • Tracks new user and inactive accounts.
  • Makes changes to user group membership as needed.
  • Performs software user acceptance testing.
  • Gathers data pertaining to customer/user needs and uses the information to identify, predict, interpret, and evaluate software/system and network requirements.
  • Assists in the research of new usage options for the system and implements it or recommends its implementation (such as protocols, ICF, study reports, source documents)

      CAPA (Corrective Action Preventive Action)

  • Conducts investigations to identify root cause of problem; recommends corrective and preventive actions and prepares reports.
  • Performs tracking, trending, and following-up to corrective and preventive actions.

      Audits

  • Assists in external audits (i.e. sponsor, third-party and ISO audits, regulatory inspections)
  • Participates in conducting internal audits. Assists in developing corrective and preventive action plans.
  • Tracking and trending of audit findings and corrective and preventive actions. 

       Training

  • Performs SOP/WI training.
  • Provides training in the use of eDMS.
  • Maintains SOPs and WIs binders and indexes.
  • Maintains metrics pertaining to quality system activities as assigned.
  • Assists with ISO 9001 certification implementation. 
  • Performs other responsibilities as required.

Qualifications

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education/Experience:

Associate or Bachelor’s degree plus 2 years of quality assurance experience in clinical research environment (i.e. pharmaceutical, CRO, or medical device company) and at least six months’ experience of electronic document management systems administration.

 

Skills, Knowledge, and Abilities:

Sound knowledge of Good Clinical Practice and FDA regulations/guidelines for clinical research/ ICH. Demonstrates strong attention to detail and organizational skills. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Ability to self-monitor progress and complete assigned tasks independently. Strong interpersonal skills and ability to work as an effective team member and with cross-functional groups.

 

Language Ability:

Highly developed verbal and written communication skills. Ability to read and interpret documents such as safety rules, WIs, SOP’s, medical terminology and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.

 

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

 

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

 

Computer Skills:

To perform this job successfully, an individual should have excellent computer skills with working knowledge and proficiency in the current Microsoft Office Suite of programs. Must have electronic document management experience. Ability to quickly learn and use new software systems.

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl.

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