Laboratory Investigator


Tampa, FL


Laboratory Investigator


The Analytical Laboratory Investigator is responsible for reviewing the completeness, accuracy and cGMP compliance of the data and documentation generated in the Quality Control laboratory. The position requires a strong knowledge of analytical testing in a cGMP Quality laboratory, good interpersonal skills and time management.


  • Work in collaboration with responsible to the complaints and deviations departments.
  • Responsibility for writing a detailed report on the analysis of the complaints, review and approve deviation reports.
  • Training and qualification of new employees in job duties according to Standard Operating Procedures (SOP), current Good Manufacturing Practices, (cGMP) and Company training procedures
  • Requires review, approval, and on time closure of the investigation
  • Reviews and approved Finished Products/ Raw Materials Certificate of Analysis and other relevant documents.
  • Improving processes related to complaints and deviations.
  • Implementation of corrective actions, CAPA and CAPA Effectiveness management.
  • Making decisions in real time according to the organization's procedures.
  • Overall responsibility for the quality of the company's products.
  • Work with many different interfaces in Israel and abroad.
  • Work in compliance with quality KPIs and goals in accordance with the organization's requirements.
  • Handling and approval investigations related to validation batches deviations and Out of Specification / Out of Alert Limit / Atypical results during stability study running.
  • Ensure proper Corrective and Preventive Actions implementation and Effectiveness Checks in relevant topics.
  • QA support, handling and approve activities related to new products introduction.
  • Support regulatory inspections during preparation and execution.
  • Strong understanding, knowledge and working according to cGMP, Corporate and Site SOP requirements
  • Review, evaluate and approval of product specifications, product’s manufacturing and packaging master documentation, stability protocols.
  • Assessment and approval of product validation and/or characterization protocols and reports.
  • Evaluation, task managements and approval Change Control Requests for Raw and Packaging Materials, Product’s pre and post approval changes, production and packaging documentation changes etc


  • Responsibility for handling complaints and deviations
  • Responsible for managing Customer Complaints and Site Deviations.
  • Ensure performs and approve comprehensive investigations of manufacturing and laboratory Out of Specification / Out of Alert Limit / Atypical results related deviations, root cause analysis and quality impact assessments. Evaluates impact and recommends final disposition of product/batches involve
  • Act as a Subject Matter Expert during regulatory and internal audits.
  • Responsible for meeting business demands with respect to release testing of parenteral drug products.


  • Responsibility for handling complaints and deviations
  • Maintain a culture of enhancing quality throughout the entire Laboratory Performance of in-depth root cause analyses and problem solving.
  • Experience and knowledge in analytical methods for glycoproteins. Experience and in particular in HPLC/UPLC, MS(advantage)
  • Basic knowledge in GLP/GMP guideline


  • Masters’ or Ph.D degree in Chemistry/pharmaceuticals sciences/Biology/Life Science or any other relevant degree.
  • 3+ years proven experience in pharmaceutical industry; QA background.
  • Strong communication/interpersonal skills.
  • Strong analytical mindset, attention to details.
  • Proficient using computerized systems, including Microsoft Office applications.
  • High English level.

Preferred Additional

  • Good teamwork capabilities.
  • Pharmaceutical/Bio Pharmaceutical laboratory experience is required.
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