Quality Specialist II - Records

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

The QA Specialist II 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

• Provide Quality expertise and oversight of the batch disposition process which includes assessment of documentation to ensure quality and compliance by site procedures and cGMPs.
• Responsible for compilation and review of batch release documentation packages (BPR, LPR, COA/COC, etc.)
• Daily interaction with cross-functional teams including but not limited to Planning, Operations, and Business Management to assist with troubleshooting, documentation corrections/notes, and guidance.
• Aids in identification of continuous improvement opportunities; participates in practical process improvement initiatives.

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• Bachelor's degree, preferably in technology, engineering or microbiology, or related field preferred.
• High school diploma or equivalent required.

• 3+ Years Preferred with previous experience in cGMP or Pharmaceutical, Medical Device, or related manufacturing industry.

• Equivalent combinations of education, training, and relevant work experience may be considered.

• Proficiency in using technology and computers, including common software applications and tools, is required (Microsoft Office Applications, Microsoft Excel, SAP, TrackWise, etc.)
• 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.