QA Oversight Specialist – cGMP & Audit Readiness

TechDigital Group; New Brunswick (NJ); Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Join a forward-thinking company as a Quality Assurance Specialist, where you will oversee critical quality processes in a dynamic environment. This role involves managing CMO oversight, ensuring compliance with GMP standards, and preparing for regulatory audits. You will play a vital role in maintaining product quality and safety, collaborating with various teams to implement business objectives. Ideal candidates will have a strong background in Quality Assurance within the pharmaceutical or biotechnology sectors, with excellent attention to detail and communication skills. This is a fantastic opportunity to contribute to high-quality standards and make a significant impact in the industry.

Qualifications

• 5+ years of experience in Quality Assurance within the pharmaceutical industry.
• Hands-on experience with QA systems and compliance with GMP.

Responsabilités

• Provide oversight for CMO Batch Production Records and ensure compliance.
• Assist with preparation for FDA audits and manage CAPAs.

Connaissances

Quality Assurance

GMP Compliance

Documentation Review

Effective Communication

Problem Solving

Formation

BS in Life Sciences

Outils

Quality Management Systems

Batch Production Records

Description du poste

Core Technical Skills:
• Install, configure, and manage IBM Db2 for z/OS environments in a Parallel Sysplex architecture.
• Install, configure, and administer IBM Db2 Tools and Utility Suites.Strong knowledge of Db2 systems programming, utilities, and database administration.
• Establish policies and procedures pertaining to database management, disaster recovery, security, maintenance, and utilization.
• Review new IBM Db2 Tool releases and functionality, providing recommendations on adoption and business value.
• Evaluate change requests and determine impact to assigned client environments.
• Provide vendor consultation and technical guidance for Db2 Tools migration activities.
• Lead and execute migrations from Broadcom/CA Db2 Tools to IBM Db2 Tools.
• Convert Broadcom/CA Db2 Utility JCL, Procedures, and Control Cards to IBM Db2 Utilities standards.
• Develop project plans with defined phases including assessment, conversion, implementation, testing, cutover, and post-migration support.
• Validate converted jobs, procedures, and utilities to ensure operational readiness and compliance with IBM standards.
Optional Skills:
• Broadcom/CA Db2 Tools administration experience.
• IBM Db2 Tools implementation and support experience.
• z/OS scheduling and automation expertise.
• Mainframe systems programming experience.
• Db2 DBA experience.
• JCL, REXX, ISPF, and utility automation skills.
• SMP/E installation and maintenance experience.
Database Skills:
• Database Administration
• Db2 for z/OS subsystem administration and maintenance.
• Database, Tablespace, Index, and Catalog management.
• Db2 Utility execution, monitoring, and optimization.
• Backup, Recovery, and Disaster Recovery procedures.
• Database change management and migration processes.
• SQL performance analysis and tuning.
• Utility scheduling and automation.
• Database monitoring and reporting.
• Space management and capacity planning.
• Package, Plan, and Access Path management.
• Performance diagnostics and workload analysis.
• Production support and problem determination.
IBM DB2 Tool Migration Skills
• Conversion of Broadcom/CA Db2 Utility JCL and Control Cards to IBM Db2 Utilities standards.
• Delivery and validation of converted Db2 Jobs, Procedures (PROCs), and Control Cards.
• Analysis of existing utility execution processes and implementation of IBM best practices.
• Development of migration standards, testing strategies, and cutover procedures.
• Install, configure, and manage IBM Db2 for z/OS environments in a Parallel Sysplex architecture.
• Install, configure, and administer IBM Db2 Tools and Utility Suites. Strong knowledge of Db2 systems programming, utilities, and database administration.
• Review new IBM Db2 Tool releases and functionality, providing recommendations on adoption and business value.
• Lead and execute migrations from Broadcom/CA Db2 Tools to IBM Db2 Tools.
• Convert Broadcom/CA Db2 Utility JCL, Procedures, and Control Cards to IBM Db2 Utilities standards.