Document Control Specialist – Quality Assurance

document-control-specialis, quality-assurance
Posted 1 week ago

Integrated BioTherapeutics (IBT) seeks to hire a Document Control Specialist to support the Quality Assurance Department. The candidate will store, manage, and track the documents associated with IBT’s Quality Management System. In addition, this role will proactively maintain a strong level of visibility and control over document and training managements systems through accurate reporting and compliance tracking.

Essential Job Responsibilities

  • Execute and maintain the Document Control program per IBT QMS and regulatory policies.
  • Copy, distribute, and maintain hardcopy of documents per IBT QMS.
  • Support Document Change Requests.
  • Train personnel on the Document Control process.
  • Maintain employee training files
  • Create new or revise existing SOP’s.
  • Perform periodic document reviews
  • Assist in deviation and root cause investigations.

Qualifications

Candidate must possess a Bachelors’ degree preferably in Biological Sciences/related degree with 0-5 years of experience with:

  • Previous experience in or competency with GMP/GLP/FDA/ISO environment a plus
  • Highly detail-oriented and organizational skills
  • Strong record-keeping and technical writing skills
  • Proficiency with Microsoft Word, Excel, Powerpoint, Adobe Acrobat
  • Strong oral and written communication skills

Research Associate – Assay Development and Bioanalytics

Integrated BioTherapeutics (IBT) seeks to hire a Research Associate to conduct immunoassay development and perform serological, microbiological and molecular biological laboratory procedures supporting the company’s internal and bioservices activities. The candidate will conduct assigned laboratory activities supporting the design of new products in the realm of assay development or the modification of existing products for new applications. The Candidate will be expected to work independently and be responsible for planning, organization and execution of laboratory tasks. Candidate will be expected to report results with accuracy and proper quality control compliance and prepare scientific reports and presentations.

Essential Job Responsibilities

  • Develop procedures for novel immunoassays.
  • Create experimental design and methods
  • Perform serological assays such as ELISAs in blood, serum and plasma samples.
  • Experience with chromatography methods is a plus.
  • Review and summarize data for reporting to the supervisor and/or team.
  • Complete a variety of tasks to ensure smooth overall function of laboratory, including simple equipment maintenance, maintain accurate inventories and proper record keeping.
  • Comply with applicable safety procedures including those for working with infectious microorganisms.

Qualifications

Candidate must possess a Bachelors’ degree in Biological Sciences/related degree with 5 years of experience or a Masters’ degree with 3 years of experience in:

  • Serological assays such as ELISAs and cell-based assays.
  • Aseptic cell culture techniques.
  • Knowledge in protein characterization such as SDS gel and western blots.
  • Familiarity with analytical methods such as HPLC is a plus
  • Excellent computing skills and familiarity with Microsoft Office (Excel, Outlook, Word, and PowerPoint), Softmax Pro, and Prism is required.
  • Willingness to work with biological specimens.

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