1 hour

QA Inspector

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343



































 


Job Description


 


 


 


 


 


Job Title:


QA Inspector


Department:


QAQC


Reports to:


Quality Assurance Manager


FSLA Status:


Non-Exempt


 


 


 


 



SUMMARY


 


Monitor manufacturing operations for compliance to Standard Operating Procedures (SOPs) and cGMPs.


Perform daily audits within the facility for compliance. Assist with verification of critical manufacturing and packaging processes. 


 


PRINCIPAL DUTIES AND RESPONSIBILITIES



  • Review all Batch Record documentation and Protocol procedures documentation to ensure they are being followed accurately by employees.

  • Issue labeling materials to manufacturing and ensure correctness and completeness of work performed

  • Verify that all manufacturing areas in operation are following current Good Manufacturing Practices (GMPs) and specific standard operating procedures (SOP).

  • Perform internal daily and routine audits of all systems within the operation. Document the results of audits performed and inform management of noncompliant issues.

  • Working knowledge of GMPs and FDA Guidance Documents is essential to this function as well as proven ability to be detail oriented.

  • Provide support to other departments as needed.

  • 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 GMPs and FDA Guidance Documents. The requirements listed below are representative of the knowledge, skills and/or abilities required. 



  • Associate degree or equivalent job experience

  • Knowledge of manufacturing operations utilizing GMPs.  Some pharmaceutical experience preferred

  • Detail oriented

  • Writing and basic computer skills (Microsoft Word and Excel)

  • Ability to interact with many departments



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 primarily in a manufacturing environment also with some desk time.


 


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 stand for long periods of time. The employee is occasionally required to walk, stoop, kneel, crouch, and climb on step ladder 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: 2020-09-27 Expires: 2020-10-27

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QA Inspector

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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