Title- Quality Specialist II
Location: Detroit, MI
Duration: 6 months+
Job ID - TMO-REQ-010778
The Quality Specialist II provides specialized services and support to a plant and/or unit. The associate used enterprise systems to develop quality system and technical document revision and/or release product. May maintain the specific portions of an enterprise system; may engage in data management; may lead quality projects.
This position defines the Release Control Administrator, Quality Notification (QN) Coordinator, Training Coordinator, Stability Coordinator, Deviation Waiver Coordinator, and Quality Lab Support functions for the Thermo Fisher Detroit plant. The position requires the timely entry of various forms of data to meet production and quality goals, and review of records and data for completeness and GMP compliance. Associate will perform final release of incoming raw materials and outgoing products. Associate will coordinate investigations into quality issues via QNs. The position requires training support as DLA or LPC, document control support for the Quality Department, and quality control support for the Quality Lab as needed. This position is the Subject Matter Expert (SME) for quality management systems and development of databases. Tracking and reporting of metrics is be required. Leading CAPAs may be required.
Duties and Responsibilities:
• Adhere to GMP and ISO requirements.
• Follow all safety and housekeeping rules and procedures.
• Maintain neat and orderly work area.
• Ability to work overtime as required to meet business goals and requirements
• Within the Quality Management department,
Is required to
• Creation/revision of documents
• Perform quality data entry into new computer systems
• Maintain the QN Program
• Maintain the Training Program
• Maintain the Deviation Waiver System
• Maintain the Stability Program
• Maintain Quality Management Systems
• Assist with data gathering for audits and represent assigned programs
• Maintain the Quality Record File Room
• May be required to lead CAPAs
Within the SAP Enterprise System (in support of the Quality Department)
Is required to
• Perform word processing of red-lined and new documents (ITs, IFMs, SBs, etc.)
• Route documents for review and approval, & coordinate responses to annotations
• Route ECOs for review and approval, & manage communications related to ECO release
• Perform Result Recording and make Usage Decisions for all ROH and HALB
• Create Quality Notifications from Inspection Result Failures
• Maintain Quality Inspection and Past Due Listing
Within the Quality Control Lab, may be required to
• Review and audit Batch History Records and test sheets for completeness, accuracy, and compliance to GMP, and track, report, and maintain GMP error files
• Maintain all filing fort ROH and HALB Batch History Records
• Assist Quality Lab with support functions as needed, such as purchasing and administration
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
• Support manufacturing batch record review for adherence to Good Manufacturing Practices (GMP) and site procedures and perform quality monitoring rounds on the manufacturing floor.
• May be required to develop databases (Access) to support the facility.
• Basic knowledge of the pertinent Quality Systems/Regulations (i.e. Good Manufacturing Practices, ISO, FDA)
• The ability to work in teams and independently with supervision to obtain results as required
• Effective verbal and written communication skills
• Must be self-motivated, organized, detail oriented, and have ability to multi-task
• Capable of readily identifying and analyzing routine problems
• Capable of using Microsoft programs. Database and enterprise systems such as SAP. Ability to learn other systems.
• Ability to create documents from rough drafts
• Ability to troubleshoot files and systems
Education: Bachelor’s degree required.
• Two years experience in Quality Systems
• Technical writing
• Proficiency in Microsoft Office (including Access) required.
• Working knowledge of Good Manufacturing Practices
• Experience in SAP preferred but not required.
Good Manufacturing Practices
Product Quality Assurance