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Specialist Quality Assurance

West Greenwich, RI
Top 3 Must Have Skill Sets:
  • GMP Bio pharmaceutical Experience either manufacturing or Quality– must have minimum 2-3 years
  • Quality Experience of GMP Operations – 2 yearms

Day to Day Responsibilities:
  • Quality oversight of manufacturing operations
  • 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
Summary
  • The Quality Assurance Specialist will be responsible for PQA On the Floor in support of Manufacturing activites.
  • This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
  • This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.
  • Amgen’s Quality Assurance On-the-Floor position Shift 2 (4 days a week Tuesday through Friday 10 hours per day 1pm – 11pm provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems with the adaptability to support alternate shifts as the business need requires.
Responsibilities include the following:
  • Provide Quality oversight 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.
Basic 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

Preferred Qualifications
  • Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
  • 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 Amgen while interacting with representatives of regulatory agencies
  • Experience of trending analysis
  • Demonstrated proficiency using Excel, Word and Power Point
         "This posting is for Contingent Worker, not an FTE"
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