Qureos Mentor

Integrated Resources, Inc ( IRI )

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 Key Objectives/Deliverables:
 
 
 
 &bull; Serve as a liaison between Contract Manufacturers(CMs) and Client.
 
 
 &bull; Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.
 
 
 &bull; Provide quality oversight of CM method validation or method transfer activities
 
 
 &bull; Escalate quality issues at CMs to Client QA management.
 
 
 &bull; Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
 
 
 &bull; Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
 
 
 &bull; Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.
 
 
 &bull; Participate in regulatory inspection preparations with CMs.
 
 
 &bull; Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
 
 
 &bull; Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.
 
 
 &bull; Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
 
 
 &bull; Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
 
 
 &bull; Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.
 
 
 &bull; Participate in APR activities.
 
 
 &bull; Participate in projects to improve productivity.
 
 
 &bull; Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
 
 
 
 
 
 Basic Requirements:
 
 
 &bull; BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
 
 
 &bull; 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.
 
 
 &bull; Additional Preferences:
 
 
 &bull; Testing experience with Small Molecule
 
 
 &bull; Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
 
 
 &bull; Knowledge of pharmaceutical manufacturing operations.
 
 
 &bull; Demonstrated coaching and mentoring skills.
 
 
 &bull; Experience in root cause analysis.
 
 
 &bull; Demonstrated application of statistical skills.
 
 
 &bull; Demonstrated strong written and verbal communications skills.
 
 
 &bull; Strong attention to detail.
 
 
 &bull; Proficiency with computer system applications.
 
 
 &bull; Excellent interpersonal skills and networking skills.
 
 
 &bull; Ability to organize and prioritize multiple tasks.
 
 
 &bull; Ability to influence diverse groups and manage relationships.
 
 
 &bull; Must be able to support 24 hour/day operations.
 
 
 &bull; Up to 20% travel US &amp; OUS.
 
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Quality Assurance Specialist

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 Responsibilities:
 
 
 
 &bull;Performs routine and complex laboratory procedures with emphasis on Oncomine Dx testing.
 
 
 &bull;Assists in the analytical validation of test methodologies for use in the laboratory.
 
 
 &bull;Assists in troubleshooting technical challenges with assays and equipment.
 
 
 &bull;Strictly adheres to testing protocols.
 
 
 &bull;General laboratory assistance, including but not limited to: receiving lab supplies, DNA/RNA isolation, preparation of reagents, building NGS libraries, sequencing DNA/RNA material, data analysis, report generation and maintenance of laboratory equipment
 
 
 &bull;Provide written and verbal communication of test results in lab reports and team meetings, delivering accurate results in a timely manner.
 
 
 &bull;May train other employees
 
 
 &bull;Utilizes good documentation practices (GDPs) and follows laboratory quality control (QC) and quality assurance (QA) policies
 
 
 &bull;Complies with safety policies and procedures
 
 
 &bull;Ensures compliance with all health and safety, CLIA, CAP, and NYSDOH regulations
 
 
 &bull;Other duties as assigned.
 
 
 
 
 
 
 Qualifications and Experience:
 
 
 
 &bull;A BS degree in Biological Sciences from an accredited college or university
 
 
 &bull;Minimum of
 
 3 years of direct experience
 
 required in a related field such as
 
 molecular oncology, genetics, or genomics.
 
 
 
 &bull;Experience with
 
 NGS experimental design
 
 and data analysis
 
 
 &bull;Experience with
 
 lab equipment
 
 including, but not limited to:
 
 QuantStudio, Genexus, Ion Chef, Ion S5, PGM system, KingFisher Flex, Veriti Thermo Cycler, pipettes, Sanger Sequencing.
 
 
 
 
 
 
 
 Skills:
 
 
 
 &bull;Use of computer systems for data entry, retrieval, and analyses involving word processing programs, spreadsheets containing data analyses, and complex computer driven instrumentation.
 
 
 &bull;Strong communication and interpersonal skills, both oral and written, with supervisor, team, and various cross-functional project team members.
 
 
 &bull;Ability to problem solve highly complex analyses.
 
 
 
 &bull;Strong analytical skills
 
 
 
 &bull;Ability to work independently and in a team setting.
 
 
 &bull;Self-motivated, diligent, and flexible in accommodating shifting priorities.
 
 
 
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Molecular Scientist

Join Integrated Resources, Inc ( IRI ) and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Integrated Resources, Inc ( IRI )

About Company

Quality Assurance Specialist

Molecular Scientist