Job Title
Quality Assurance SpecialistRequisition
JR000015214 Quality Assurance Specialist (Open)Location
Dublin, IRLAdditional Locations
Job Description Summary
The Quality Assurance Specialist is responsible for maintenance of the Quality Management Systems within the College Park manufacturing facility. This position will have a wide range of tasks which include the performance of investigations related to deviations, nonconformances, and out-of-specification/out-of-trend events. The Quality Assurance Specialist will also own and/or lead the corrective and preventive actions that are identified as a result of those investigations. This individual is responsible for the trending and metric reporting of the quality management system elements at the College Park manufacturing facility. The Senior Quality Assurance Specialist will also serve as a lead on quality projects and as the quality representative on site-wide projects or those assigned by management.Job Description
Principal Responsibilities
- Perform and evaluate trending of the Quality Management Systems to support management reviews, investigations, and continuous improvement initiatives (i.e. quality management reviews, annual product quality reviews, trend analysis for quality events, etc.)
- Interpret and properly apply all applicable regulatory requirements
- Lead and/or support investigations through cross functional team involvement (i.e. RCA, etc.)
- Present investigations and deliver disposition recommendations to site leadership and Qualified Persons.
- Improve existing procedures or create new procedures to align with cGMP and regulatory requirements
- Review and approve procedures, protocols, reports, etc., as required
- Lead and/or assist with continuous improvement, compliance-based, and site projects
- Support lean manufacturing initiatives both at the site level and within the greater Quality/Operations organization
- Participate in internal audits as an SME or member of the audit team
- Participate in External audits as a member of the audit team
- Perform additional duties as directed by management
- Approval of Change Proposals for GMP impacting changes on site at CPMF
- Support the day to day management for QA Team and associated workload.
Department specific/Non-essential responsibilities:
- Support other Quality functions at the site through cross-training opportunities
- Drive Continuous Improvement projects on site from a Quality Perspective
- Ensure Compliance with current regulatory requirements
Minimum Requirements
Experience / Skills:
- Bachelor’s degree or higher in a scientific discipline (biology, chemistry or engineering)
- 2+ years of experience in a cGMP environment
- Effective communication, coaching/mentoring, and presenting skills
- Ability to manage change
- Self-motivated
- Independent and sound decision making capabilities
- Team-oriented
- Project Management skills
- Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
- Deliver on-time results / Time Management
Competencies/Certifications:
- Proficient with the Microsoft Office Suite, especially Excel, Word, and PowerPoint
- Technical writing
- Technical competency in analytical testing
Organizational Relationship/Scope:
The Quality Assurance Specialist collaborates closely with Manufacturing, Quality Control, EHS, Engineering, and Maintenance. This individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position’s working hours are during normal site hours M-F, but may be required to work extra hours or on weekends or holidays in order to support site activities. This position reports directly to the Quality Assurance Lead.
Working Conditions:
The Quality Assurance Specialist will mainly work in an office environment but will also be required to work in the manufacturing and QC environments when providing QA support to those functional areas.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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Mallinckrodt Pharmaceuticals Dublin, Dublin, IRL Office
College Business & Technology Park,, Dublin, Ireland
