- Effectively implement and maintain the product complaints program and the quality risk management process at the Port Allen facility
- Perform review and approval of OOS, deviation, nonconformance, investigations and Validation/Qualification Records as required
- Lead product investigations and corrective action initiatives, as deemed necessary.
- Establish, implement, and manage quality standard operating procedures and policies
- Perform other tasks as deemed appropriate by management, including but not limited to batch record review and product release, quality systems review and approval, site assessments, and project support.
- Conduct investigations, perform risk analysis, and deliver disposition recommendations; assist with writing, revising, and approving standard operating procedures.
- Maintain site-specific documentation to comply with company policies, procedures, and regulations; lead continuous improvement activities based on quality metrics.
- Participate in auditing activities and serve as SME for regulatory quality services inquiries and documentation requests.
- Serve as a QA representative for site and internal company projects; promote the company's vision and values, ensuring safe, clean, orderly, and compliant work areas.
- Associate's degree in any discipline with 5+ years of Quality Assurance experience required.
- Bachelor's degree in a science/technology discipline with 5+ years of experience in a regulated environment, cGMP preferred.
- Proficient in effective interpersonal communication, teamwork, and leadership, with strong organizational skills and attention to detail.
- Skilled in written and oral communication, and highly competent in Microsoft Office tools, including Excel, Word, and PowerPoint.
- Ability to work independently and be self-motivated
- Lean Management, Six Sigma, experience preferred
Quality certificate preferred (ASQ CQE, CQM, CQA, etc.) - Working knowledge of Regulations & Compendium Reference Materials and cGMPs
- General knowledge of standard quality techniques
- Demonstrated abilities in working with Regulatory Agencies in inspections
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Senior Quality Services Coordinator - Port Allen, United States - Mallinckrodt
Description
Job TitleSenior Quality Services Coordinator
Requisition
JR Senior Quality Services Coordinator (Open)
Location
CC-Port Allen - USA502
Additional Locations
Port Allen, LA
Job Description
The Senior Quality Services Coordinator is responsible for the coordination of the facility's product complaint program ensuring appropriate evaluations of complaints are performed in a manner compliant with national and international regulations, company policies, and company SOPs.
The Senior Quality Services Coordinator will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, SOP review and revision, trending and reporting, deviation investigation, audit support, and direct involvement and collaboration with the Product Monitoring, Manufacturing, Materials Management, Quality Control, Validation and Engineering groups to drive quality culture.
In addition, the Senior Quality Services Coordinator has project-support responsibilities, serving as a quality representative for both site-specific and company-wide projects.
Essential Functions
This position reports locally to the Quality Assurance Manager. The Senior Quality Services Coordinator directly collaborates with and supports Product Monitoring, Manufacturing, Materials Management, Quality Control, Validation and Engineering functions. This will be part of the Quality Assurance (QA) Department of the Site Quality Department located at the Port Allen, LA drug and medical device manufacturing facility. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. Additional duties to support functions outside of the Port Allen facility may be assigned.
Working Conditions:
The Senior Quality Services Coordinator typically works in an office setting, with interaction in the manufacturing areas. The hours will consist of one either four 10s or five 8s, depending on need of site.
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