Senior Quality Assurance Specialist - Computerized Systems

Camarillo, CA
Full Time
Experienced
Company: PBS Biotech, Inc.
Department:Quality
Position/Title:Sr. QA Specialist – Computerized Systems
Location:Camarillo, CA
Reporting To:Dir. of Quality Management
FLSA Status:Exempt
Pay Range:$104,300 – $116,450 - $127,850
 
GENERAL PURPOSE
In accordance with the QMS and Quality Policy, the Sr. QA Specialist – Computerized Systems is responsible for supporting the implementation of a computerized system program. This includes implementation, deployment, and maintenance of computerized systems at PBS Biotech, Inc. (PBS).

this role supports the implementation and continuous improvement of PBS’s Quality Management System (QMS). Oversees assigned quality related programs and processes such as the computerized system program. Supports GxP compliance and regulatory related requirements, audits, and customer requests. Interfaces with QMS and eQMS users to define, implement, and improve assigned QMS processes and procedures.

Knowledge and experience with Quality Management System (QMS) and electronic Quality Management System (eQMS) is required. Additional leadership and project assignments will be assigned based on the needs of the business.
 
Responsibilities
Essential functions of the job are listed below.  Other responsibilities may also be assigned.  Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Primary 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.
  • This role is considered a QA function and may provide QA approvals where assigned.
  • Will be assigned additional tasks and projects as needed to meet business objectives.
 
Minimum Qualifications
The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.  Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

The position requires experience with deployment and maintenance of computerized systems in a GMP environment. This role requires effective leadership, collaboration, technical writing, and verbal communication skills. 
 
Knowledge/ Experience
  • BA/BS w/ 10+ 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.
 
Skills/ Abilities Pertinent to This Position
 
  • 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.
 
PHYSICAL DEMANDS
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing and test equipment.  May occasionally required to lift various weights up to 50lbs as needed to meet job requirements.
 
WORK ENVIRONMENT
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment.  May be required to perform some tasks in the following environments: Clean room; Near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant. Personal protective equipment (vision and hearing) used in plant. 
 
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