U.S. Pharmacopeial Hiring Quality Assurance Specialist- Apply Online

Description

Brief Job Overview

This is a non-supervisory professional position responsible for supporting various Quality Assurance activities in coordination with Team lead – QA / Senior Manager/ Director (Global Quality Standards, VER & PQM+), other internal departments and international locations to carry out quality objectives and processes as they relate to providing quality systems and metrics for USP. This position is responsible for auditing, reference standard documentation reviews/release, Conducting Laboratory investigations, CAPA’s, supplier evaluations etc.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP’s public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

Perform independent laboratory project documentation audits including Analytical method validation reports, issue audit reports and adhere to achieve monthly target.
Review and approval of equipment qualification /calibration/ validation reports associated with Reference Standards development and evaluation. Additionally, review and approval of in-house equipment qualification protocols.
Conduct internal audits per ISO standards and USP In-house procedures, timely release of audit reports and ensure adequate response to the audit observations.
Review and approval of quality notifications such as Deviation, OOS/OOT, Issue (Incident), Change control, and Corrective and Preventive action (CAPA). Coordinating with CFT (Cross Functional Team) on adequate investigation, RCA, CAPA and timely closure of quality notifications.
Develop training content and deliver training to staff on ISO standards, Quality topics, QA orientation and applicable in-house procedures.
Coordinate and support QA and CFT in preparation of external ISO audits (ISO/IEC 17025 and ISO 9001).
Support in collection, compilation, and evaluation of Quality Management system data for Management review Meeting (MRM).
Review and approval of Vendor registration and evaluation process. Tracking material issues and ensure adequate investigation / CAPA. Conduct vendor audit for critical vendors and ensure compliance to ISO standards and USP supplier evaluation program.
Review of SOPs, Process / workflows, and guidelines consistent with ISO standard and USP In-house procedures.
Identify and implement appropriate actions for continual improvement of QMS at USP IN based on the trend data analysis and audit findings.
Adhere and promote USP core values & DEIB (Diversity, Equity, Inclusion and Belonging) within the department and throughout the organization.

Who is USP Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

Master’s degree in Science(M.Sc Chemistry/M.Pharm) with 5-8 years relevant experience in a pharmaceutical industry preferably working in Development QA/Analytical Reviewer role/Quality Assurance in API or formulations industry.
Minimum of three (3) years of hands-on experience in laboratory, handling of analytical equipment, qualification of analytical equipment, calibration, metrology and other laboratory activities.
Minimum of two (2) years’ experience in analytical review with good technical report writing skills, investigation of Quality notifications (OOS-OOT, Deviation, Incident, Change controls and CAPA), document control, regulatory and/or ISO audits and other QA activities.
Knowledge on Analytical Method validations and Biologics/Microbiology/Cell biology related testing is an added advantage.
Working knowledge of MS Word, PowerPoint, Excel etc.,

Additional Desired Preferences

ISO 9001 Auditor Certification and knowledge of ISO/IEC 17025
Any QA/QC course/certifications such as Diploma in Pharmaceutical Quality Assurance, Comprehensive Course in Quality Assurance and Control Systems, Good Documentation Practices, Data integrity, Investigations (Root Cause Analysis) and risk assessment is an added advantage.
Understanding of GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory.
Exposure to lab software such as Laboratory Management System (LMS), NuGenesis – SDMS, Waters Empower® would be advantageous.
Working experience on QA QMS software applications such as MasterControl, MetricStream, Tracwise etc.i and metrics would be advantageous.
Strong knowledge of MS office tools such as Word, Excel, and power point presentation.
Demonstrate ability to build strong, credible working relationships across an organization.
Excellent written and verbal communications skills.

Supervisory Responsibilities

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.