| Job Description: |
The Labeling Specialist (CM-QA2) 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 specialist 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 specialist shall be a passionate advocate for Quality in all aspects, and be a constant driver for results.
* Most importantly, the Specialist shall display a customer service attitude when coordinating with various members of the team.
*The Labeling Specialist 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.
* 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 Specialist must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
*The Labeling Specialist shall be primarily responsible for organizing and executing projects related to medical device labeling changes, and become the Subject Matter Expert (SME) with regard to medical device labeling issues.
* He/she will coordinate with Division and Facility team members, including Project Management Office, Regulatory, Marketing, Quality, Technical Operations, and Manufacturing groups to ensure the new/changed labels are implemented within the regulatory requirements and approved project parameters.
* He/she will provide guidance for label changes for component, in-process, and finished goods packaging utilizing industry best practices and regulatory expertise.
* The Labeling Specialist shall be responsible for routing and facilitating all copy approval projects, be the point of contact person for all copy approvals, must be highly detailed oriented, attend teleconferences and meetings for both internal and external customers, The Labeling Specialist will be responsible for processing the 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 label changes are effectively accomplished with high quality and in a timely manner.
*The Specialist shall additionally act as a Change Control Specialist and be responsible for supporting the overall Change Management system.
* He/she will responsible for facilitating projects related to product, process, and/or equipment changes within the facility.
* He/she will coordinate with a diverse team to ensure changes are implemented within the regulatory requirements and according to cGMP.
* The Change Control Specialist will be responsible for processing the 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.
* He/she may approve minor changes and make recommendations for the approval of 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.
*The Specialist shall also occasionally assist the overall Quality Systems Department with various 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.
* Requirements A Bachelor of Science degree or equivalent experience.
* (Engineering or Microbiology degree or experience preferred).
* A minimum of 3-5 years GMP medical device experience A minimum of 2 years directly as a quality associate dealing with Regulatory and Medical Device labeling issues subject to audit by FDA, EU, and other notified bodies.
* A minimum of 1 year directly as a quality associate dealing with equipment and process change control in the GMP Medical Device arena.
* 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.
* Experience creating, managing, and querying databases and generating reports Extensive experience analyzing and summarizing technical data via common statistical tools (e.
*g.
* MS Excel) and generating official reports.
* Experience of performing risk-based assessments and determination of work requirements Experience determining impact to product/process quality Experience with Deviations, Exceptions, and/or Non-conformances.
* Experience with validation of equipment, facilities, and processes.
* Familiarity with ISO grade clean room environment, and support facilities.
* A keen insight and inclination towards Quality.
* Familiarity with QC laboratory operations and test methodology.
* Must be comfortable around, and be able to 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 perform as the delegate manager of the Change Management group as needed Ability to support scheduled tasks during off-hour times when needed.
* Reports to the Manger of Change Management.
*Baxter stands for high-quality products, excellence in service and integrity in business practices.
* We are strongly committed to addressing and meeting the needs of our customers, to building successful relationships with our suppliers, and caring for our world community.
*If you have a desire to learn, grow and innovate, you can find purpose and satisfaction at Baxter, and make a contribution to a greater good.
*Percent Travel Required0%
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