Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Deviation Management Specialist

How will you make an impact?

We are seeking a highly organized and diligent Deviation Management Specialist to join our team. The Deviation Management Specialist will be responsible for coordinating all aspects of the deviation process and providing administrative and operational support to the deviation management process. The ideal candidate will have excellent organizational skills, communication skills, strong attention to detail, and the ability to work collaboratively with cross-functional teams.

• Assist in the maintenance of accurate and up-to-date deviation documentation, including deviation records, investigation reports, and associated documentation.
• Enter and track deviation-related data in designated systems or databases, ensuring accuracy and completeness of information.
• Facilitate effective communication and coordination between various partners involved in the deviation management process, including Quality Assurance, Manufacturing, Process Engineering, and other relevant departments.
• Ensure proper filing and archiving of deviation-related documents in accordance with company policies and regulatory requirements.
• Collaborate with cross-functional teams to gather necessary information and documentation for deviation investigations, ensuring timely and accurate completion.
• Assist in the generation of deviation metrics and reports, highlighting trends and providing insights for continuous improvement efforts.
• Provide training and support to employees involved in the deviation management process, ensuring adherence to established procedures and guidelines.
• Ensure compliance with applicable regulatory requirements, industry standards, and internal policies throughout the deviation management process.
• Contribute to the identification of process improvement opportunities and support the implementation of corrective actions to prevent deviations from recurring.

• Bachelor's degree in a scientific or engineering field is preferred.

• 2+ years of experience, preferably in a cGMP environment

• Strong attention to detail to accurately record and maintain deviation-related documentation.
• Excellent organizational skills to manage multiple tasks, prioritize workload, and meet deadlines.
• Effective written and verbal communication skills to collaborate with various partners and convey information clearly and concisely.
• Proficient in using common software applications, such as MS Office suite, SmartSheet, Trackwise, and data management systems.
• Ability to work collaboratively in a team-oriented environment and build positive relationships with colleagues.
• Flexibility to adapt to changing priorities and work under pressure in a fast-paced environment.