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Document Control Specialist, San Diego, CA

Company: Kelly Services
Location: San Diego
Posted on: April 9, 2021

Job Description:

Document Control Specialist, San Diego, CAPosition Type:--Temp-to-HireShift:--1st, Monday- FridayPosition Summary: This position is responsible for supporting all document control activities in accordance with company processes, 21 CFR Part 210 and 211. Competent with Microsoft office is a must for this position. Requires working and interacting with different employees of the company.With minimal supervision, able to perform routine tasks such as copying and filling various documents, updating SOP manuals, creating files, retrieving and delivering documentation per internal or external request, and generation of laboratory notebooks.An organized, detailed oriented, and team player person is essential for this position due to high volume of work and interaction with all employees. Knowledge of electronic documentation systems (EtQ Reliance, LIMS, MasterControl, or Documentum) is a plus and may be involved in the administration, testing, and/or improvement of new Part 11 electronic systems and other supporting systems. Must have the ability to apply acquired knowledge of GMP to daily tasks. Knowledge of cGMP, GLP, ISO regulations are a plus.Essential Duties and Responsibilities:

  • Applies GMP in all areas of responsibilities
  • Demonstrates and promotes company vision
  • Regular attendance and punctuality
  • Performs all Document control functions in compliance with quality policy and regulatory requirements
  • Accurately maintains and archives company documentation
  • Retrieves and delivers internal and external customer-requested documentation in a prompt manner
  • Communicates effectively with departments and internal customers. Has limited contact with external customers.
  • Generates document numbers, and creates / assembles laboratory notebooks.
  • Trains new employees on all aspects of Document control position.
  • Administers and manages Document control and Training system database and Part 11 systems.
  • Verifies copies or scanned documentation to ensure that the secondary copy is accurate.
  • Formats and trains on Standard Operating Procedures and support Quality Audits.
  • Routes SOPs for review and approval as hardcopy or through EtQ Reliance and provides guidance to authors writing or revising SOPs.
  • Keeps current with project closeout and archival
  • Attends training programs as needed to satisfy regulatory requirements
  • Supports new quality initiatives and continuous improvements.
  • Conducts all activities in a safe and efficient manner
  • Performs all other duties as assignedJob Requirements:
    • High school diploma or equivalent; must be able to type 45 wpm.
    • Ability to work effectively under pressure to meet deadlines.
    • Excellent verbal communications skills.
    • Good judgment, decision making, and problem solving.
    • Positive attitude and has willingness to learn.
    • Excellent secretarial skills and attention to detail; good grammar, spelling, filing, and punctuation proficiency; cooperative and pleasant with coworkers and clients; versatile concerning workload whether it is data entry, word processing, or taking a jam out of the copier; handle sudden changes in workload, schedules, and a willingness to adjust to corporate needs; good organizational skills and meticulous work habits; work independently; willingness to work overtime; pride in appearance, conduct, and company; communicate effectively, both orally and in writing; ability to lift 25 pounds; organized and logical thinking process; follow detailed verbal and written instructions; medium stress level.Physical Requirements:
      • On an average day this position requires the ability to clearly see and focus on objects at close and far distances with good depth perception, talk or hear (95-100% of working hours or continuously); sit, use hands to handle or feel (80-94% or essentially); reach with hands and arms (50-79% or frequently); stand, walk, lift up to 25 pounds (10-49% or occasionally); climb or balance up to one hour; stoop, kneel, or crouch, (1-9% of working hours or infrequently).
      • Employee must wear Personal Protective Equipment (PPE), when required, including but not limited to filtering face masks etc. when working in the laboratory or manufacturing areas of the facility.For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656, Email at grap467@kellyservices.com, or--schedule a time to connect directly follow the link:--Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, San Diego , Document Control Specialist, San Diego, CA, Other , San Diego, California

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