Group Leader- Quality Control/Technical Writer, Bioanalytical Services
Exton, PA (Corporate)
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 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.
- 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
- 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.