18 days old

Document Control Specialist

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343
































 


Job Description


 


 


 


 


 


Job Title:


Documentation Specialist


Department:


QAQC


Reports to:


Documentation Control Manager


FSLA Status:


Non-Exempt


 


 


 


 



SUMMARY


 


This is a critical position which is responsible for the processing and maintaining GMP documents throughout its lifecycle as well as performing quality reviews of production records to support the release of materials and finished products.


 


PRINCIPAL DUTIES AND RESPONSIBILITIES



  • Word process, update, track changes and distribute all GMP/GCP documents as required

  • Review and release of raw materials, components

  • Review production batch records for accuracy, integrity and completion

  • Issuance of Working Batch Records

  • Maintain the QA document filing and record retention system for GMP records in accordance with internal procedures.

  • Copy/provide documents and records filed in the Document Control Records room to BLI personnel as necessary

  • Maintain the schedule for Triennial review of documents

  • Reporting of assigned Quality Metrics on a monthly basis

  • 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 Microsoft Office as well as experience in FDA regulated environment. The requirements listed below are representative of the knowledge, skills and/or abilities required. 



  • Ideal candidate would have a degree in an industry related field (preferred) or equivalent experience, with proven English skills

  • Proficiency in Microsoft Office including Microsoft Word and Excel

  • Excellent written and verbal communication skills, including technical writing skills

  • Exceptional organizational, attention to detail and document management skills

  • Experience with document control software (ZenQMS, SOLABS, QMAS, Share Point, etc.) preferred.

  • Ability to multi-task

  • Experience in a pharmaceutical or biotech manufacturing environment preferred

  • Light travel is possible



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: 2020-10-09 Expires: 2020-11-08

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Document Control Specialist

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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