Laboratory Investigator

12/22/22

Tampa, FL

1882

Laboratory Investigator

PURPOSE:

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.

SUPERVISORY RESPONSIBILITIES:

  • 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

MAJOR DUTIES AND RESPONSIBILITIES:

  • 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.

SKILLS AND ABILITIES:

  • 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

EDUCATION AND EXPERIENCE:

  • 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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