Biotech Production Compliance Coordinator II

Rensselaer, New York
May 06, 2022
Required Education
Associate Degree
Position Type
Full time

We are currently looking to fill a Biotech Production Compliance Coordinator position with a 1st shift, Monday-Friday, 8:00am – 4:30pm 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.

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.

This role might be for you if you:

  • Excel in a quality driven organization.
  • Can manage multiple assignments and changing 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).

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.

Does this sound like you?  Apply now to take your first steps toward living the Regeneron Way!  We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.  We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.  Please contact us to discuss any accommodations you think you may need.