The QA Specialist 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.
What will you do?
Provide Quality expertise and oversight of the batch disposition process.
Perform quality assessments of documentation to assure quality and compliance by site procedures and cGMPs.
Responsible for compilation and review of batch release documentation packages (BPR/LPR/COA/COC).
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance.
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.
How will you get here?
Education
Bachelor's degree, preferably in technology, engineering or microbiology, or related field preferred.
High school diploma or equivalent required.
Experience
2 to 5 years of experience with previous experience in Quality Assurance or Quality Control or 5 to 7 years of Operations/Manufacturing or other pharmaceutical experience in regulated environments is preferred.
Knowledge, Skill, and Requirements
Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
Knowledge of Quality oversight of batch disposition.
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.
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