Job Description

Job Opportunity

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description:

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Investigate and observe Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product registrations are followed and maintained. Conduct investigations of batches, preps, lots, equipment, and facilities in accordance with the Code of Federal Regulations. Assist the Operations and Quality Operations departments in satisfying all FDA and DEA requirements.

What will you do?

• Investigate deviations to identify the probable root cause of the incident and corrective actions.
• Determine if batch is acceptable to release, or to deny release, what corrective actions are necessary and provide follow-up to ensure that corrective actions have been implemented.
• Assure review of incident by appropriate level of management and must notify management of serious incidents that require management's review and action.
• Conduct GMP inspections of facilities to assure compliance with the current GMP regulations.
• Perform housekeeping inspections to assure Operations is maintaining work areas in an orderly and clean manner.
• Conduct cleaning inspections of equipment and areas.
• Recommend changes to batch records for clarification and compliance. Assure that operators are following written instructions and methods.
• How will you get here?

Education: Bachelors Degree in Chemistry, Biology, Engineering or relevant science preferred.

Experience: Minimum of 3 years experience in Records, QC, QA, Analytical Development, Process Engineering, Engineering services or manufacturing.

Equivalency: Equivalent combinations of education, training, and related work experience may be considered.

Knowledge, Skills, Abilities:

• Requires extensive understanding of the practices, principles and theory of GMP Services
• Must be able to identify and analyze unique problems.
• Excellent problem solving and writing skills
• Strong Proficiency in Microsoft Office Suites
• Ability to work on multiple projects simultaneously
• Strong attention to detail
• Technical writing knowledge
• Root cause analysis experience.

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