| Job Description: |
The Quality Systems Specialist (QS-QA3) will be a driven, hard-working, hands-on, high achiever that actively leads him/her self and others to the end of successfully accomplishing complex and multi-faceted tasks. The QS-QA3 shall demonstrate the proven capability to define, plan, and execute a project involving a diverse cross-functional team. Additionally he/she shall be a highly proficient communicator, both verbal and written, and be able to convey complex ideas and concepts to other team members that may have differing technical backgrounds. He/she shall be an excellent technical writer with a mastery over the English language. The QS-QA3 shall be a passionate advocate for Quality in all aspects, and be a constant driver for results. Most importantly, the Quality Systems Specialist shall display a customer service attitude when coordinating with various members of the team.
The QS-QA3 shall demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. He/she shall lead Greenbelt and Kaizan or equivalent focus type group activities as required, and may serve as a CAPA owner and lead investigator. As needed, he/she will effectively supervise others in the accomplishment of tasks, holding others accountable for success, while engendering a sense of purpose and direction. The QS-QA3 must be recognized by all levels of the facility as an expert in multiple areas and be able to demonstrate leadership ability.
The Quality Systems Specialist shall be primarily responsible for, or acting as:
* Subject Matter Expert (SME) for change control issues, including organizing and executing projects related to product, process, and/or equipment changes.
* Subject Matter Expert (SME) for exception management issues, including organizing and executing projects related to exceptions, nonconformances, and CAPAs.
* Subject Matter Expert (SME) for validation issues, including organizing and executing projects related to product, process, and/or equipment validation.
* Subject Matter Expert (SME) for quality engineering issues, including organizing and executing projects related to product, process, and/or equipment design assurance and control.
* Subject Matter Expert (SME) for supplier quality issues, including organizing and executing projects related to materials and supplier control.
* Perform as the delegate manager of the Change Management group as needed
* Perform as the delegate manager of the Quality Systems department as needed
* Providing guidance to customers and users regarding the various quality systems.
* Provide innovative solutions and drive Quality Systems initiatives for continuous improvement, regulatory compliance, exception management, and systems validation. When called upon, he/she may write, compile, execute or otherwise accomplish technical and administrative tasks as needed.
* Coordinating with Division and Facility team members to establish the best approach for implementation of Division Procedural initiatives.
* Coordinating with Division and Facility team members, including Project Management Office, Regulatory, Marketing, Quality, Technical Operations, and Manufacturing groups to ensure new/changed processes and equipment are implemented within the regulatory requirements and approved project parameters.
* Providing guidance to various internal customers for the change control process related to components, in-process product, finished goods, packaging, and equipment utilizing industry best practices and regulatory expertise.
* As required, approving, reviewing, and/or making recommendations for major changes. For each change he/she will establish or determine testing criteria, effectiveness tests, on-status release requirements, affected documentation, and state of validation.
* Processing changes through the quality system, which includes data compilation, word processing, recording and entry of the changes via the paper and/or electronic change management systems, and other tasks that ensure that the changes are effectively accomplished with high quality and in a timely manner.
* Supporting the overall Change Management system, which includes document, label, and component (Item) control.
* Accomplishing Certificates of Compliance that ensure that all local SOPs are in compliance with Baxters divisional and corporate policies and procedures.
* Accomplishing periodic reviews of documents which ensures that all controlled documents are reviewed for technical and formatting content on a regular basis.
* Reporting metrics for the various quality systems as needed.
* Reporting to the Senior Manger of Quality Systems Requirements * A Bachelor of Science degree or equivalent experience. (Engineering or Microbiology degree or experience preferred).
* A minimum of 6-10 years GMP experience (medical device preferred). A minimum of 5 years directly in a quality or similar role dealing with process and equipment quality issues subject to audit by FDA, EU, and other notified bodies.
* ASQ certification or training helpful
* Previous experience in leadership roles.
* Previous experience with project management
* Proficient in conveying concise and direct ideas to management, with defined recommendations for action.
* Experience with CFR 820 QSRs, CFR 210 & 211, current FDA guidance, and ISO 13485 and their practical application.
* Familiar with Design Control, Design History Files, Device Master Records, and Risk Assessment.
* Extensive experience writing, revising, and reviewing SOPs.
* Extensive experience reviewing and/or revising documentation for technical and non-technical accuracy, completeness, and adherence to local and higher-level procedures.
* Extensive experience analyzing and summarizing technical data via common statistical tools (e.g. MS Excel) and generating official reports.
* Experience with Product/Process Lifecycle documentation, including writing and approval.
* Experience creating, managing, and querying databases and generating reports
* Experience performing risk-based assessments and determination of corresponding work requirements
* Experience determining impact to product/process quality
* Experience writing and approving Deviations, Exceptions, CAPAs, and/or other Non-conformances.
* Experience writing, executing, and/or approving the validation of equipment, facilities, and processes.
* Familiarity with ISO grade clean room environment, high-purity water and gases, and other support facilities.
* Familiarity with QC laboratory operations and test methodology.
* Must be a strong Quality Advocate with a keen insight and inclination towards Quality.
* Must be comfortable around, and be able to positively assert, quality-oriented ideas to engineering and highly technical personnel.
* Experience training others in various quality systems
* Experience participating in audit situations
* Ability to independently generate audit item remediation action plans and develop schedules and timelines accordingly.
* Ability to support scheduled tasks during off-hour times when needed.
Percent Travel Required 0%
Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers. EOE M/F/D/V.
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