26 days old

Stability Coordinator

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343
































 


Job Description


 


 


 


 


 


Job Title:


Stability Coordinator


Department:


QAQC


Reports to:


Senior Manager, Compliance


FSLA Status:


Exempt


 


 


 


 



SUMMARY


 


Laboratory Administrative Position that oversees the stability program for all products


 


PRINCIPAL DUTIES AND RESPONSIBILITIES


 



  • Oversees the stability program, associated protocols, and reports.

  • Generate stability protocols describing materials, storage conditions, test methods, and study duration.

  • Maintains stability sample inventory and coordinates sample submissions with outside testing laboratories.

  • Ensures stability chambers organization, maintenance, and support troubleshooting.

  • Input data or facilitate its input into stability database as it is generated

  • Perform trending and/or statistical analyses of data as directed in support of process trending, laboratory investigations, regulatory filings, or annual reviews.

  • Coordinate the proper storage of stability samples with associated personnel as well as the pull schedule of stability samples for routine testing.

  • Perform training on procedures, regulatory requirements, and database use.

  • Individual contributor may be assigned as a project lead or trainer commensurate with experience or expertise.

  • Responsibilities may be designated as a collateral duty.

  • Participates in continuous quality improvements.

  • Other duties as assigned



 


 


QUALIFICATIONS


 


To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in Current Good Manufacturing Practices and ICH Guidance for Stability. The requirements listed below are representative of the knowledge, skills and/or abilities required. 


 



  • Minimum Baccalaureate degree in Physical Science or Mathematics, or related discipline

  • Minimum 2 years experience in a CGMP environment, preferably in a stability function



 


WORK ENVIRONMENT


 


The work environment described here are representative of those an employee encounters while performing the essential function of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will be in an office environment.


 


PHYSICAL REQUIREMENTS


 


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit for long periods of time. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Categories

Posted: 2022-04-20 Expires: 2022-05-20

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Stability Coordinator

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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