Senior Quality Specialist (Computerized Systems)

We are a Privately owned Biotechnology company. We design and manufacture the most advanced electromechanical systems for the Medical Device & Pharmaceutical Industries. These systems are used for R&D to clinical to GMP production. Our systems help save lives!

SUMMARY:
As our Senior QA Specialist for Computerized Systems is responsible for implementing and maintaining computerized systems in line with the Quality Management System (QMS) and Quality Policy. This includes deployment, maintenance, and continuous improvement of systems, as well as supporting overall QMS implementation and improvement. They oversee quality-related programs, ensure compliance with standards and regulations, handle audits and customer inquiries, and collaborate to enhance processes and procedures. Expertise in QMS and eQMS is required, with the potential for additional leadership and project assignments.

MUST HAVES:

• Systems Administration.
• Validation of the EQMS (Electronic Quality Management Systems – such as with BMRAM, VEEVA, track wise, master control, etc.)
• GMP experience.
• Documentation/testing for the computerized systems.

DUTIES & RESPONSIBILITIES:

• Support the company’s efforts for cGMP qualification and ISO 9001:2015 certification
• Supports the development of the computerized systems program.
• In collaboration with stakeholders, support the deployment and implementation of computerized systems (e.g., electronic Learning Management Systems (LMS) and Electronic Document Management System (EDMS), ERP, software development, etc.).
• Maintains and continues to develop computerized systems by creating, reviewing, and approving procedures and supporting documents.
• Support of computerized system applications through validation, maintenance, quality administration (such access control, system periodic review, etc.), training, and process improvement initiatives and activities.
• Support Computerized System Assurance (CSA) and Computer System Validation (CSV) (develop and execute documentation for qualification and validation activities to support various computer system validation projects.
• Perform failure analysis, risk assessments, and solve problems and addresses/advises on issues such as deficiencies, deviations, change control, etc.
• Conducts external and internal audits associated with computer systems for privacy, GxP and other compliance frameworks, and supports development of overall audit process for IT in conjunction with the corporate quality and compliance functions.
• Ensure compliance of computerized systems to relevant regulatory requirements (e.g., GxP/GAMP).
• Draft templates for High-Level Risk Assessments, User Requirements Specification, Validation Plans, Validation Documents and Protocols (e.g., DQ, IQ, OQ, PQ, Trace Matrices, etc.) and Validation Summary Reports.
• Establish and implement reporting tools for analysis, trending, and reporting metrics.
• Assist with the development and implementation of SOPs, training materials, work instructions, etc.
• Act as liaison between Quality Assurance and project teams to assure that computerized systems are implemented in compliance with applicable regulations and guidelines.
• In collaboration with stakeholder, lead and support the development of a validation remediation strategy for GxP systems.
• Responsible for managing, coaching, and training project/internal resources, as needed.
• Maintain a state of inspection readiness and participate in inspection preparation activities.
• Support internal and external audit and inspection activities.
• Support QMS initiatives as assigned.

EDUCATION & EXPERIENCE:

• BA/BS in Pharma, Biotech, Software, or Computer Science.
• 5+ years of relevant experience with Pharmaceutical Quality systems.
• Experience in implementing and/or supporting one or more following Quality applications: Electronic Quality Management Systems, Electronic Document Management Systems, Learning Management System.
• Experience interfacing with stakeholders to deploy and improve computerized systems.
• Extensive knowledge of project management and system development methodologies.
• Excellent verbal and written communication skills including excellent technical writing skills.
• Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
• Experience with a quality management system in drug/biotech/pharma (21CFR210/211), medical devices (21 CFR 820, ISO 13485/14971) or medical products (ISO 9001, ISO 13485).
• Experience with software, computerized systems, and/or control system validation.
• Experience with eQMS (EDMS, LMS, etc.). Experience with Veeva eQMS, CMMS (BMRAM), and EPR (GSS) is a strong plus.
• Excellent technical writing and excellent verbal communication skills.