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Group Leader- Quality Control/Technical Writer, Bioanalytical Services

Group Leader- Quality Control/Technical Writer, Bioanalytical Services

Exton, PA (Corporate)

Position Summary

Reporting to the SVP of Bioanalytical Services, the GL of Quality Control/Technical Writer is responsible for the overall operations of the QC and Document Control Group.

Duties

  • Duties include the management of all activities of the Quality Control/Technical Writer group
  • Ideal candidates will have experience in managing direct reports and t timelines of associated with individual report deliverables
  • Knowledge and understanding of bioanalysis with a focus on LC-MS/MS, LBA, and GLP regulations is required
  • Previous laboratory experience in these areas is preferred
  • This position is also responsible for ensuring all documents meet the highest quality standards before they are submitted to both external and internal clients
  • Ideal candidates must be able to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
  • Candidates must be detail-oriented with a strong knowledge of English composition and grammar.

Responsibilities

  • Review lab notebook and data package from scientific staff
  • Write method validation, sample analysis reports, study protocols/plans and bioanalytical methods
  • Manage bioanalytical documentation
  • Oversee the proper use and completion of the documentation change control forms (DCC)
  • Assist client audits and communications
  • Experience in Document Control responsibilities Previous experience in a contract research organization (CRO) is preferred

Requirements

  • Masters or Bachelor scientific degree in pharmaceutical sciences, immunology, biology or a related field
  • Knowledge of Bioanalysis with a focus in LC-MS/MS, LBA, and GLP regulations
  • Minimum of 5-7 years of industrial experience in Quality Control and Document Control
  • Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required
  • Working knowledge and experience with Watson LIMS system is preferred Familiar with pharmaceutical RD process
  • Demonstrated capability and confidence to build, train and lead a group Hands-on laboratory experience is preferred
  • Experience working in a CRO or with CROs Good interpersonal communication skills; excellent oral and written English
  • Qualified candidates should forward their resume to HumanResource@frontagelab.com. Please reference the job title in the subject line.

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