Quality Specialist II-Batch Disposition

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

Summary:

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 customer expectations are met to support release.

Essential Functions:

• Provide Quality expertise and oversight of the batch disposition process which includes assessments of documentation to assure quality and compliance by site procedures and cGMPs.
• Responsible for assembling and or review of batch release documentation packages (BPR/LPR/COA/COC).
• Daily interaction with business management, planning, and technical services associates to assist with troubleshooting, documentation corrections/notes, and guidance.
• Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives.
• Responsible to support customer and or regulatory audits when needed as the Batch Disposition representative
• Responsible to attend cross-functional or customer meetings when needed

Education:

High School Diploma Required.

Associates or Bachelors Degree Preferred in, Science or applicable field.

Experience:

3-5 years' experience in QC, QA, Analytical Development, Process Engineering, Engineering services or OSD Manufacturing

Equivalency:

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

Competencies:

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

Good interpersonal and leadership skills.

Possesses exceptional time management and multi-tasking abilities to meet commitments and deadlines.

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