Intertek Analytical Services combines expertise with advanced analytical laboratory services to provide added value to clients across a wide range of industries including Upstream Oil & Gas, Refining, Chemical and Materials, Pharmaceutical and Biotechnology.
The opportunity has arisen for a Senior Quality Assurance Associate to join this global organization which respects diverse perspectives, experiences, and traditions as essential, and values each employee’s contribution toward achieving our business objectives.
ESSENTIAL DUTIES and RESPONSIBITLIES
The Senior Quality Assurance Associate is expected to have a complete understanding of FDA, OECD, and MHLW, Good Laboratory Practices (GLP), as well as basic laboratory quality assurance procedures.
Represent the Quality Assurance Unit and interact with multiple departments to provide GLP guidance in an effective manner.
Become intimately familiar with company Standard Operating Procedures (SOPs), FDA and MHLW regulations, OECD guidelines, and other appropriate regulations and guidelines. Also be familiar with any sponsor SOPs that may apply to studies.
Review validation, sample analysis, and associated data, and reports for compliance to GLP regulations and guidelines, the study protocol/plan, SOPs, and Bioanalytical Procedures (BPs).
Determine that deviations from approved study protocols/plans or SOPs and BPs were made with authorization and documentation.
Assure compliance with GLP regulations and guidelines and company procedures (SOPs and BPs).
Submit to the Study Director and the Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken.
Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary.
Take the initiative on any QA-related issues with regards to GLP compliance.
Periodically review training records of employees.
If necessary, interact with the Sponsor QA team during visits to the laboratory as well as prepare written correspondence regarding QA audits and compliance audit findings.
Responsible for performing periodic facility inspections to ensure laboratory maintains compliance.
Responsible for performing study phase (in-life) inspections to ensure compliance and integrity of the study.
Responsible for maintaining the Master Schedule.
Support of other QA functions as needed.\
Bachelor's degree (BA or BS) required
5+ years of relevant experience in QA, QC, Regulatory Affairs, or within GXP (GCP, GLP, GMP) evnironment
Intertek offers a culture where motivated and customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. We also offer a generous compensation and benefits package including medical, dental, vision, life insurance, disability, 401(k) with company matching, tuition reimbursement, and a generous paid time off package.
Intertek - 22 months ago
Intertek is a nosy nellie when it comes to product safety and international trade. The company, a leading provider of testing and inspection...