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Specialist Quality Assurance (JP8045)

West Greenwich,, Rhode Island · Biotech/Pharmaceutical
Job Title: Specialist Quality Assurance (JP8045)
Location: West Greenwich, Rhode Island 02817
Employment Type: Contract
Business Unit: Quality Operations 
Duration: 6 months with likely extensions
Job posting date: 28 December 2020
Note: Onsite Essential. Shift schedule is Sat, Sun, Mon 7pm - 7am
3 Key Consulting is hiring a Specialist Quality Assurance for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • The actual shift schedule is Sat, Sun, Mon 7pm - 7am. For training purposes during the first week, the candidate will have to work a Mon - Fri 8am - 5pm schedule.
  • Ideal: Quality system experience. Someone who’s worked on deviation records and has been able to make decisions based on that is ideal. Drug substance manufacturing experience is a plus.
  • The Specialist will be responsible for Quality Oversight On the Floor in support of Manufacturing activities.
  • 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.
  • The client’s Quality Assurance On-the-Floor position Shift 5 (3 days a week Saturday through Monday 7pm – 7am) provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems.

Top Must have Skill Sets:
  • Previous QA oversight of manufacturing, analytical and engineering activities; experience in investigations and quality systems process knowledge. (intermediate level of experience)
  • Biotech- quality assurance/manufacturing experience (insight into quality assurance) (intermediate level).
  • Ability to gather relevant information to understand and solve complex problems and make scientific risk-based decisions. (troubleshooting experience/problem solving/ to best provide a quality assurance concepts).
  • Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with peers, manufacturing partners, and management staff.
  • This role requires a high level of communication as there are 20 people working over 5 shifts so the candidate will need to be able to effectively communicate what was done and be able to pick up and ask questions from the previous shift.
Day-To-Day Responsibilities:
  • Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
  • Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
  • Ensures 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, and Corrective Action/Preventative Actions (CAPA) records.
  • Establish and enable LEAN practices.
  • Ensures that deviations from established procedures are investigated and documented per procedures.
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alerts senior management of quality, compliance, supply and safety risks.
Employee Value Proposition:
Not working at a desk job, quality role partnership with manufacturing on their floor to insure we are compliant to FDA regulations that is safe and effective - every process operation is performed and executed, to ensure compliant drug substance manufacturing- cross collaboration between quality assurance teams and manufacturing teams (10-12 people)
Red Flags:
  • Quality Control Laboratory experience ONLY is not a good fit. We are looking for Quality Assurance experience.
  • Must have a minimum of 2 - 3 years GMP industry experience in either a Manufacturing or Quality Assurance role.
  • An introvert will not be the best fit - cross collaboration is big factor in this role!
Interview Process:  
Phone and webex. 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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