Job Details

  • Title: QA Associate
  • Code: RCI-6489
  • Location: West Greenwich Rhode Island (RI) 02817
  • Posted Date: 11/07/2019
  • Duration: 6 Months
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  Job Description

Shift 2 - 4 days a week Tuesday through Friday 10 hours per day 1pm – 11pm. Must be flexible on schedule as sometimes business needs will require CW to work 3rd shift.

The position provides coaching, guidance, and direction to Manufacturing and other functional areas such as  and Facilities & Engineering staff in regards to compliance and quality systems. Responsibilities include the following:

  • Provide Quality oversight of manufacturing operations to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA)
  • Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports
  • Establish and enable LEAN practices
  • Oversee and provide guidance during on-the-floor analytical testing
  • Ensure that changes that could potentially impact product quality are assessed according to procedures
  • Ensure that deviations from established procedures are investigated and documented per procedures
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
  • Alert senior management of quality, compliance, supply and safety risks
  • Complete required assigned training to permit execution of required tasks
  • Drive operational improvement initiatives, programs and projects
Top day to day responsibilities
  • Quality oversight of manufacturing
  • Review and approval of electronic batch records, SOP and other source documents
  • Quality review and approval on deviation
  • Real time decision making on the floor with manufacturing
Top Skills
  • GMP Bio pharmaceutical Experience either manufacturing or Quality must have minimum 2-3 years
  • Quality Experience of GMP Operations – 2 year
Qualifications
  • Doctorate degree OR Master’s degree and 1 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience OR Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience OR Associate’s degree and 5 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience OR High school diploma / GED and 7 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
  • Previous QA oversight of manufacturing, analytical and engineering activities
  • Experience in investigations, change controls, and CAPAs processes system knowledge
  • Direct Validation experience with pharmaceutical or biopharmaceutical processes
  • Ability to evaluate compliance issues and interact with regulatory inspectors
  • Experience and training in EDMQ, Trackwise, Maximo, LIMS
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Experience leading and/or managing teams
  • Direct bulk drug substance and drug product experience
  • Ability to solve complex problems and make scientific risk-based decisions
  • Experience representing client while interacting with representatives of regulatory agencies
  • Experience of trending analysis
  • Demonstrated proficiency using Excel, Word and Power Point