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Specialist QA (JP8271)

West Greenwich, Rhode Island   · Biotech/Pharmaceutical
Job Title: Specialist QA (JP8271)
Location: West Greenwich, Rhode Island    
Employment Type: Contract
Business Unit: Quality Operations
Duration: 6 months with likely extensions
Job posting date:  2.25.2021      
Note: Onsite Essential
On-the-Floor position Shift 3: - 4 days a week, Tuesday through Friday, 10 hours per day, 10pm – 8am

3 Key Consulting is hiring a Specialist QA for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Ideal candidate
  • Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies.
  • GMP Bio pharmaceutical Experience either manufacturing or Quality– must have minimum 2-3 years.
  • Quality Experience of GMP Operations – 2 year

    Job 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.
  • Quality Assurance On-the-Floor position Shift 3 (4 days a week Tuesday through Friday 10 hours per day 10pm – 8am 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.
Top Must have Skill Sets:
  • Previous QA oversight of manufacturing, analytical and engineering activities; experience in investigations and quality systems process knowledge. (beginner to intermediate level of experience).
  • Biotech- quality assurance/manufacturing experience (insight into quality assurance) (beginner to 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 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:
The person in this role will have the opportunity to work with an experienced team and improve their skills.
 
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:
  • 2 Phone interviews through Skype or Webex
  • One with hiring manager.
  • One with 5th shift Sr Manager
  • Interviews can be scheduled asap.
 
 
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.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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