Quality Assurance Specialist

Quality Assurance Specialist

job Description

  • Quality Assurance Specialist for a position based out of their Norwood, MA facility.
  • The individual in this role will be responsible for providing Quality Assurance (QA) support for Drug Secondary packaging, labeling and distribution operations at External Contract Manufacturing Organizations (CMOs).
  • The individual will primarily work with: colleagues in External Quality as well as with Supply Chain Operations and logistics, Internal Quality Assurance, CMC and external Vendors including packaging, labeling, distribution and other related service providers to support packaging and labeling activities and outbound Supply Chain for .
  • This individual will support quality oversight for packaging and labeling, perform batch record review and disposition, provide QA support of quality systems including change controls and deviations, monitor and report cold chain and temperature excursions amongst other key quality assurance activities.
  • Additionally, the individual will track and populate systems to maintain metrics and trends.
  • The successful candidate must have experience in a biotech or pharmaceutical GMP environment.
  • This position will be 1st shift working 7:00 am to 3:00 pm working Sunday through Thursday.

Here’s What You’ll Do:

  • Review, approve and disposition of packaging and labeling batch records
  • Support quality oversight of packaging, labeling and distribution vendors
  • Review and report temperature excursions and support product impact assessments based on data
  • Assist in developing and updating procedures to support commercial supply chain and distribution operations.
  • Track batch release metrics as well as vendor-based deviations
  • Track Quality Systems including Change Controls and Deviations within *** systems as well as at CMOs
  • Report temperature excursion data
  • Track metrics for key quality performance indicators for cross-functional visibility

Job Requirements:

Here’s What You’ll Bring to the Table:

  • BS in a scientific or engineering discipline with at least 4 years experience in the pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure
  • Outstanding/effective communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
  • Experience in the drug manufacturing and/or drug packaging and labeling processes
  • Experience in SAP or similar ERP system
  • Strong experience in Quality Systems managing quality events
  • Proficiency in Microsoft Office tools including Powerpoint, MS Project and Visio
  • Previous experience in a GMP environment is required
  • Experience interfacing with external partners
Norwood, MA 02062, US