The QA Specialist III-Coordinator will perform activities in support of disposition of product while ensuring compliance with Thermo Fisher directives and procedures, customer requirements, and regulatory standards. Performs Quality batch record and documentation review. Works with manufacturing and cross-functional team members to ensure deliverables are met to support release.
Essential Functions
Works directly with Planning and Business Management on Shipment Plans and MFG/PKG needs daily driving the teams daily work plan
Provide Quality expertise and oversight of the batch disposition process.
Responsible for compilation and review of batch release documentation packages.
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance.
Performs quality review and approval of procedures, training documents, deviations, CAPAs and change control and forms minor to major impact.
Perform quality assessments of facility, personnel, and documentation both classified and non-classified areas to assure quality and compliance by site procedures and cGMPs.
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.
Education
Bachelor's degree, in technology, engineering or microbiology, is preferred.
High school diploma or equivalent required with 3 - 5 years of proven track record.
Experience
> 5 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing or other pharmaceutical experience in regulated environments is preferred.
> 2 years of planning or project management experience
Experienced supervisor, or people leader with 2+ years of people leadership in a fast paced environment.
Knowledge, Skill, and Requirements
Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
Knowledge of Quality oversight of batch disposition.
Ability to work in a fast-paced environment under pressure, able to multi-task and drive for results.
Experience leading, training, and developing teams. Effective time management and prioritization skills.
Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills and good interpersonal and leadership skills.
Possesses exceptional time management and multi-tasking abilities to meet commitments and deadlines.