Quality Specialist I - 2nd Shift

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

How will you make an impact?

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.

Working Hours: Monday - Friday 2:00pm - 10:00pm

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.

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
• 2 to 5 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.