Regeneron Freshers Job – Biotech Production Compliance Coordinator Post

Regeneron Freshers Job – Biotech Production Compliance Coordinator 

Regeneron is currently looking to fill a Biotech Production Compliance Coordinator position with a 1st shift, Monday-Friday, 8:00 am – 4:30 pm schedule. This position performs compliance-related tasks associated with the change management process (change controls, corrective and preventative actions, and document workflows) to support manufacturing operations.

Job Title: Biotech Production Compliance Coordinator II

Location Rensselaer, New York, United States of America

Category General and Administrative

Job Id R6749

To be considered for this role, you must hold of the following education and/or work experience:

• Level II: Bachelor’s degree, preferably in Life Sciences or a related field, or
• AS/AAS Degree in Biotechnology/Biological Science and 0-2 years of relevant work experience
• Level III: Requires BS/BA in Life Sciences, or related field and 2 years of
• relevant experience or equivalent combination of education and experience
• Sr Level: Requires BS/BA in Life Sciences, or related field and 5 years of
• relevant experience or equivalent combination of education and experience
• Level is determined based on qualifications relevant to the role.

Eligbility Criteria: 

• Excel in a quality-driven organization.
• Can manage multiple assignments and change priorities through robust organizational, planning, and project management skills.
• Have an attention to detail.
• Have strong technical writing and interpersonal communication skills.
• Can learn and apply computerized systems for the performance of daily tasks.
• Have experience navigating a controlled quality system (preferred but not required).

In this role, a typical day might include the following:

• Independently prepares compliance documentation required to implement corrective actions and changes to various GMP processes in support of manufacturing operations, and in accordance with cGMP standards and written procedures.
• Performing administrative tasks to support manufacturing operations, as needed in accordance with cGMP standards and in compliance with written procedures.
• Processing quality instances (change controls, CAPAs, workflows) in quality systems (DocCompliance; ProcessCompliance) to update controlled documents and systems in accordance with cGMP standards.
• Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
• Facilitating or participating in cross-functional meetings to support the implementation of Corrective and Preventative Actions (CAPA’s) and process improvements.
• Independently monitoring and progressing multiple projects concurrently; identifying, addressing, and/or raising potential obstacles in a timely manner.
• Documenting all training.
• Assisting with the training of new employees.
• Ensuring all tasks are performed in a manner consistent with safety standards.

Regeneron Freshers Job

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