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Associate Quality Analyst II
Spectraforce
Prince George's County, Maryland

8 days ago

Job Description

Location: Barceloneta, PR
Pay Rate: $30.43 / Hourly

Responsibilities:
  • Maintain integration of data requirements for quality systems (SAP, Thermo LIMS, MES,ERP, etc). Perform assessment and coordination for data management opportunities.
  • Perform system maintenance activities to ensure that it is updated to the current product specifications and requirements.
  • Create and maintain Inspection Plans synchronized within the applicable systems for raw material, commodities, and manufacturing products per approved specification.
  • Create and maintain master data for raw materials, commodities and manufacturing products (Master Recipes, Bill of Materials, etc.)
  • Monitor systems data interface for troubleshooting and correction of exceptions log events.
  • Provide support to Quality Control, SCM and manufacturing personnel on day to day Electronic Batch Record (EBR) execution.
  • Create and maintain Product Master Recipes and Bill of Materials for manufacturing products.
  • Communicate with accounting, MES and Supply Chain groups for recipe generation and updates.
  • Create Change Requests for changes in master data, inspection plans and master recipes.
  • As a Quality representative, may participate in the Change Review Board (CRB) and change control assessment process.
  • Request and/or approve as SME assessment of Impact forms for raw materials, commodities and manufacturing specifications for User Site Effective.
Qualifications:
  • A completed Bachelor Degree with a minimum two (2) years of experience in Quality or Quality Systems (SAP, ERP, EBR, POMSnet and/or FLowstream).
  • Knowledgeable in LIMS system.
  • Should possess strong knowledge/application in PC's, software applications such as Excel, MS Word and Access. 
  • Must be able to communicate effectively in English and Spanish (both written and oral skills).
  • Good interpersonal skills, teamwork, analytical and problem solving skills.
  • Experience in pharmaceutical manufacturing process is desirable.
  • Ability to manage multiple and changing priorities in order to comply with business needs.
  • Proficient knowledge of Outlook and Windows.
 
Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $30.43/hr.

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