QA Specialist (9724)
PURPOSE AND SCOPE OF POSITION:
The Quality Contractor's primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. Altogether, the Contractor will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of products.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Advanced knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.
- Intermediate knowledge of Delta V, OSI Pi, LIMS
- Advanced knowledge of electronic batch records, Microsoft Word, Outlook, and Excel.
- Requires ability to communicate appropriately with regulatory agencies.
- Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles
- Intermediate problem-solving, critical-reasoning, and decision-making skills.
- Intermediate time-management, organizational, and multi-tasking abilities.
- Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
- Ability to interpret / write technical documents.
- Ability to solve routine and complex problems.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
Education and Experience:
Bachelor of Science degree required, with a minimum of 7 years of related Quality, Manufacturing, and Compliance experience in the pharmaceutical industry.
DUTIES AND RESPONSIBILITIES:
- Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.
- Drives use of best-practices during IT systems design, validation, and use.
- Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
- Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.
- Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes, but not limited to functional requirements, user requirements, and design specifications.
- Reviews and approves documents, change controls, and protocols related to IT systems.
- Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.
- Supports deviations as needed.
- Represents and leads Quality Assurance Operations for CAR T through the initiation and implementation of projects related to electronic systems.
- Manages project activities and ensures appropriate team members are assigned to appropriate activities.
- Supports continual alignment of the business process with other business functions and provide effective on-going end user support.
- Develops, maintains and improves key business processes.
- Provide training to appropriate end users as related to enterprise system implementation and updates.
- Drafts, reviews, and edits SOPs, process flow and other business documentation.
Sthree US is acting as an Employment Business in relation to this vacancy.