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Quality Assurance Specialist

Job Attributes

Job Id:

29993

Job Category:

Not Defined

Job Location:

Hanover, maryland  21076

Security Clearance:

Not Defined

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Life Sciences is actively seeking a Quality Assurance Specialist in Hanover, MD to support cGMP and GLP operations at a major biotechnology organization. The Quality Assurance Document Control Specialist will take the lead on the review, revision and completion of internal documentation.  

 Responsibilities for the Quality Assurance Specialist 

  • Implement and Maintain the EDR (electronic data record) within GMP/GDP (good manufacturing practices / good documentation practices)
  • Assist with issuance of tracking numbers for Quality Systems (Change Controls, Deviations, CAPA, Document numbering, Logbook Issuance, etc.)
  • Review of documents created by others for accuracy, clarity, formatting, and compliance to cGMP/GDP requirements
  • Type new and revised Standard Operating Procedures (SOPs), raw materials, packaging materials, drug product specifications, testing procedures, forms, Certificates of Analysis (C of A’s)
  • Create document control requests to revise/update documents
  • Assist with issuance of tracking numbers for Quality Systems (Change Controls, Deviations, CAPA, Document numbering, Logbook Issuance, etc.) 

Qualifications for the Quality Assurance Specialist 

  • Bachelor’s degree in Biology or similar discipline
  • 1+ years of experience working with QA or QC
  • 1+ years of documentation experience within a GMP regulated facility
  • Experience with electronic document repositories and LIMS

Compensation for the Quality Assurance Specialist 

  • Salary commensurate with experience
  • Medical, Dental, Vision, 401k

 

Please send all qualified resumes to Michael Epstein at mepstein@pipercompanies.com

 

 

 

Keywords: document control, quality assurance, gmp, glp, cgmp, manufacturing practices, biotechnology, biologics, gene therapy, medical, dental, vision, 401k, upstream manufacturing, downstream manufacturing, cell culture 

 

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New Search

Job Id:

29993

Job Category:

Not Defined

Job Location:

Hanover, maryland  21076

Security Clearance:

Not Defined

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions