Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
At Thermo Fisher Scientific Inc., we are driven by our mission to enable our customers to make the world healthier, cleaner, and safer. We are currently seeking a dedicated and daring Quality Specialist III-Supervisor Batch Disposition to join our world-class manufacturing team in the United States. This is an outstanding opportunity to chip in to the perfect execution of our batch disposition operations and ensure the highest standards of quality and compliance.
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What you will do
Work directly with Planning and Business Management on shipment plans and MFG/PKG needs, driving the team's daily work plan to ensure results are met.
Lead the batch record disposition team to achieve site goals for delivery and accuracy promptly.
Provide Quality expertise and oversight of the batch disposition process, ensuring compliance with all relevant directives and procedures.
Compile and review batch release documentation packages to ensure they meet our stringent quality standards.
Engage daily with employees to assist with troubleshooting, documentation corrections/notes, and provide mentorship.
Perform quality reviews and approvals of procedures, training documents, deviations, CAPAs, change control, and forms with minor to major impact.
Conduct quality assessments of facility, personnel, and documentation in both classified and non-classified areas to ensure adherence to site procedures and cGMPs.
Identify continuous improvement opportunities and participate in practical process improvement initiatives.
Education
High School Diploma Required. Bachelor's degree or equivalent experience, preferably in technology, engineering, microbiology, or a related field.
Experience
Proven experience of more than five years in Quality Assurance, Quality Control, Operations/Manufacturing, or other pharmaceutical experience in regulated environments is helpful.
Equivalency
Equivalent combinations of education, training, and meaningful work experience will be considered.
Knowledge, Skill, and Requirements
In-depth knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
Proven knowledge of quality oversight in batch disposition.
Outstanding organizational skills, analytical and problem-solving abilities, strong verbal and writing skills, and good interpersonal and leadership skills.
Demonstrated ability to handle time effectively and multi-task to meet commitments and deadlines.
Ability to influence without authority and work collaboratively within cross-functional teams.