Supplier Quality Specialist Job Description
Supplier Quality Specialist Duties & Responsibilities
To write an effective supplier quality specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included supplier quality specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Supplier Quality Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Supplier Quality Specialist
List any licenses or certifications required by the position: ASQ, PMI, ASQC, MRB, PE, CQE, A&P, FAA, LEAN, NDT
Education for Supplier Quality Specialist
Typically a job would require a certain level of education.
Employers hiring for the supplier quality specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Technical, Science, Education, Chemistry, Manufacturing, Business, Microbiology, Industrial, Associates
Skills for Supplier Quality Specialist
Desired skills for supplier quality specialist include:
Desired experience for supplier quality specialist includes:
Supplier Quality Specialist Examples
Supplier Quality Specialist Job Description
- Assisting in audit preparation to enable a Third Party Auditor to perform supplier audits
- Performing ad-hoc reporting on selected KPIs
- Manage most investigations (deviations and market complaints) in partnership with TLCT, QC, Belgium manufacturing facilities and suppliers to identify and follow up root causes and CAPA’s, product impact assessment
- Escalate suppliers/quality issues to stakeholders through appropriated escalation processes
- Perform and/or support supplier quality system audits on request and assess supplier capability to meet product requirement specifications
- Perform supplier performance measurement activities to improve compliance across the supply base
- Manage current regulatory requierements, internal, environment related to incoming materials
- Promote continuous improvements and customer focus spirit"
- Manage most investigations (deviations and market complaints) in partnership with Technical Lifecycle team, Quality Control, Belgium manufacturing facilities and suppliers to identify and follow up root causes and CAPA’s, product impact assessment
- Manage current regulatory requirements, internal, environment related to incoming materials
- Attendance of shift and shortage meetings (Audit, Start-of-Shift, End-of-Shift ) when necessary
- Monitor quality improvement plans at supplier
- Ensure supplier notifications of quality escapes are processed as required
- 1+ years’ experience pharmaceutical industry preferred
- Knowledge of FDA cGMP as described in 21 CFR Parts 11, 210 and 211, applicable FDA and ICH Guidelines required
- 1+ years' experience in negotiation of Quality Agreements or contracts required
Supplier Quality Specialist Job Description
- Review and release of batch and controlled documents (change controls) and compliance certificates from CMO's for correctness of raw materials, packaging components, labeling materials, distribution of samples, QC technical data, resolution of nonconforming lot, and physical release of product
- Maintain compliance with FDA & EU regulations in review and investigation of deviations, customer complaints, field alerts, vendor issues, validation documents for all products released into market place from CMO's
- Responsible for assuring compliance of suppliers and CMO's to BIVI specifications for contract manufactured product through audits (on site via controlled documents/records) and communications with vendors and BIVI internal partners to ensure compliance to registration and cGMPs
- Travel extensively to on-site vendor locations
- Audit Report writing
- Assists with audits and assessments of supplier's systems, processes and products to determine compliance with requirements and documents results
- Attack Plans
- CTQ monitoring
- Site NC for SQ related
- Supplier Change / Deviation Management
- Working knowledge and experience with ERP enterprise software such as SAP is desirable preferred
- Experience in FDA/partner inspections is desirable preferred
- Monitor Quality Improvement Plans at supplier (QIP)
- Knowledge of regulatory requirements ISO 13485, 9001, 17025 and the IVD Directive
- Plan SQ surveillance activities and participate as a member of the Enterprise SQ Surveillance
- Support future business needs to identify areas of development for improving the performance and productivity of the supplier base
Supplier Quality Specialist Job Description
- Participate in design changes related to supplier provided materials
- Take the quality lead role in working with suppliers on existing process improvements to develop supplier’s processes, process validations and ensure the necessary process controls and documentation
- Conduct trend analysis on key performance metrics related to supplier’s non conformities as results of audits, complaints and receiving inspections
- Support Machine/Material interface issues identified at the Breweries related to Brewing Materials
- Partner with Supplier Quality Management and Procurement on the development and approval of quality assurance agreements with suppliers
- Ensure Quality at the Source for selected Key Suppliers
- Lead Continuous Improvement Projects at suppliers
- Perform Root Cause Analysis of non-conformances and lead implementation of corrective & preventive actions
- Conduct supplier quality system audits and follow up activities
- Develop First Article and Production (as applicable) Inspection and Test Plans and manage the suppliers’ execution of these plans
- Develop visibility tools to monitor performance of high risk supplier networks
- You are the interface to manufacturing in a quality expert role externally internally with high attention of the management of production
- You have a solid experience in application of Quality-methods and statistics, PPAP, SPC, MSA, APQP
- Plan, conduct and report external supplier / contractor audits and assessments in line with external audit Standard Operating Procedures (SOPs)
- Ensure audit files are set up and maintained for all audits and assessments performed
- Ensure corrective action activities associated with all audit observations are agreed and completed in a timely manner
Supplier Quality Specialist Job Description
- Report to supervisor in time for findings of supplier’s issue on manufacturing process control and nonconforming product information during final inspection and shipment packaging inspection
- Follow up supplier’s disposal of nonconforming products, and perform necessary re-inspection
- Manage Supplier quality performance
- Execute special projects, as assigned by supervisor
- Participates in root cause analysis and supports resolution of supplier corrective action plans
- Perform vendor site assessments with documented results as part of Pre-Award Approval process
- Perform vendor site assessments to deploy risk management techniques for suppliers with continued poor performance or otherwise negatively impacting quality and deliver metrics
- Maintains and distributes assigned tasks
- Performs duties safely and in an environmentally responsible manner
- Performs Supplier Audits of Classified and Major suppliers, Processors and Service Providers, as applicable
- Present concise and accurate information for queries on external audits as required
- Assist with the setting up and participating in meetings with relevant staff in order to discuss audit /assessment findings
- Educated to BSC level in a relevant scientific topic or appropriate experience in a pharmaceutical environment
- You must also be able to travel to contractors and supplier sites that deliver into both the Bolton and Bathgate facilities
- Bachelors degree in an Engineering, Finance, Economics, Business, or related technical background
- Minimum of 3 to 5+ years of supplier quality experience
Supplier Quality Specialist Job Description
- Coordinates answers to Supplier Reports and Corrective Actions (Facilitates Root Cause Corrective Action activities with Suppliers as a result of Audit, Compliance, or Product deficiencies or escapes.)
- Performs source inspections of product
- Provides input and data for CAB I and CAB II meetings (Corrective Action Board)
- Supports cross functional teams engaged in continous improvement initiatives
- Performs various administrative activities related supplier quality information in the companies ERP system
- Independently determines and develops approaches to and solutions compliantly within policies & procedures
- Support Customer Service organization on RCCA on Buy part returns as necessary
- Familiarity with Metrology/Calibration for purposes of audit and measurement system analysis
- Member of Supplier Quality Management (SQM) team in the deployment of the SQM strategy and monitoring of supplier quality continuous improvement
- Manage, develop, implement, and maintain quality improvement programs
- Minimum of 2+ years working directly with suppliers
- Experience in the pharmaceutical, food, cosmetic, personal care or medical device industry, deployment of Quality Systems, process controls and/or continuous improvement methods (QSRs, ISO 9001, ISO 14001, RC 14001, ISO13485 or ISO 22716)
- Certified to a nationally recognized quality certificate is desired
- Quality Systems and Supplier Management Requirements
- Bachelors degree in a related field + 4 years manufacturing experience OR a minimum of eight (8) years manufacturing experience
- Communicate effectively both verbally and written with supplier and internal personnel in a professional manner