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Quality Assurance (QA) Assistant

BioAgilytix Durham, NC

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

BioAgilytix is a leading contract research organization (CRO) that specializes in large and small molecule bioanalysis. Our fully integrated laboratory services support every stage of biologics development, from early discovery through pre-clinical studies and clinical phases, in a fully regulated environment. The best science demands the best people, and our global team of professionals in Durham, North Carolina; Boston, Massachusetts; San Diego, California; and Hamburg, Germany bring a passion for helping pharma and biotech companies achieve more for the patients they serve.


The Corporate Compliance Assistant | Assistant Archivist is responsible for providing QA administrative assistance to the regulatory document management systems. He or she assists the Archivist in ensuring all Corporate GLP, GCP/GCLP and GMP (GxP) activities related to hard copy and e-archive systems are compliant with the current internal procedures and GxP national/international regulations and guidances.


Essential Responsibilities

  • Scan documents and/or certify the copy of a scanned document
  • Prepare data through staple and paperclip removal, removal of data from protective sleeves, etc.
  • Paginate data through use of a paginator, stamp, scanner, etc.
  • Assist Archivist with the operation, review, and procedure for archiving (hard copy and electronic records) in accordance with BioAgilytix SOPs and relevant GxP regulations
  • Assist in other Quality projects as needed, including but not limited to providing audit and inspection support
  • In absence of the Archivist, fulfill the duties of the Archivist as listed below and in the BAL SOPs

Archivist

  • Ensure that access to the electronic and hard copy archives are controlled
  • Ensure all records are orderly stored
  • Ensure that the retrieval of records/materials will be facilitated by a system of indexing to ensure that the movement of records and materials in and out of the archive is properly controlled and documented
  • Other duties as assigned

Minimum Acceptable Qualifications

Education/Experience:

  • High school diploma
  • Not less than two (2) years' administrative experience

Skills:

  • Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
  • Ability to take direction well and multi-task
  • Acute attention to detail and organizational skills
  • Excellent oral and written communication skills

Preferred Credentials

  • Associate degree in biology, biotechnology, business administration, or related field
  • Not less than two (2) years' experience in a laboratory environment, preferably in a GLP, GMP, or regulated facility

Working Environment

  • Primarily office
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Physical Demands

  • Ability to work in an upright and/or stationary position for up to eight (8) hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
  • Occasional mobility needed
  • Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moving) objects, including files and a laptop computer, with a maximum lift of 20 pounds
  • Ability to access and use a variety of computer software
  • Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
  • Ability to perform under stress and multi-task
  • Regular and consistent attendance

Position Type and Expected Hours of Work

  • Full-time position
  • Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
  • Occasional weekend, holiday, and evening work required


Job Posted by ApplicantPro

BioAgilytix

Address

Durham, NC
27713 USA

Industry

Technology

View all jobs at BioAgilytix