Quality Specialist

Date Posted
March 24, 2022
Location
Job Category
Quality

About Adesis

Adesis, a Universal Display Company (Nasdaq: OLED), is a contract research organization (CRO) supporting the pharmaceutical and biopharmaceutical industry, biotech, specialty chemistry and electronic industries. We specialize in organic and organometallic synthesis, from milligrams to multi-kilogram quantities. Our business model provides clients with organic chemistry services in three areas: early-stage research, scale up and development, and specialty manufacturing. We have an exceptional technical team and pride ourselves in our ability to solve challenging chemistry problems for our growing client base.

Adesis is an extraordinary company looking for extraordinary talent! Our mission is “Accelerate our clients’ success through innovative chemistry and solutions” and our vision is “Innovate for life.” – innovate for our clients, our colleagues, and our legacy.

Adesis offers promising careers where we live our values of innovation, ownership, and integrity.

Position Summary:

Adesis is seeking an experienced quality control and/or assurance expert to help build, secure and measure a quality culture across a very high growth and fast paced company.  This expert will be a critical part of the Quality Organization and will help apply industry knowledge, discipline and simplification efforts across the whole of Adesis.  Adesis is experiencing unprecedented growth and this role will need to work across boundaries, home in on stakeholder communication and ensure quality is pragmatically promoted, documented and simplified to ensure commitment from all stakeholder groups. 

Duties and Responsibilities:

  • Support Head of Quality in developing and securing a “quality culture” comprised of disciplined, industry leading, and pragmatic processes and measurements across a R&D and Manufacturing roadmap.
  • Support the mission, vision, values, and culture of Adesis.
  • Build upon existing processes to ensure quality control and assurance models but challenge with a continuous improvement mindset on process and approach.   
  • Help drive simplification of records, control points, governance tactics and/or document repositories alongside ISO and Good Regulated Practice (GxP) standards and methodology.
  • Knowledge in change controls, SOP development, material specification, batch record and CoA development required.
  • Working experience in development and/or maintaining Quality Management Systems (QMS) and operating models
  • Commitment to company stakeholders, teamwork oriented and reliable when executing quality control measures
  • Independently represent discipline, best practice and company standards when performing quality control check points and execution of company protocols
  • Supports internal audit assessments and identifies areas to audit based on risk potential, existing risks to operating model and stakeholder input.
  • Help the Head of Quality develop best industry practice standards to ensure Adesis is exceeding customer expectations through control points and requirements.
  • Work to simplify QC processes and eliminate QC complexities through improving the employee knowledge of quality controls and ensure client standards and Adesis’ internal operations are accounted for.   
  • Ensure that quality related efforts will be managed systematically and holistically and measured as such.
  • Set QC/QA objectives, communicate expectations, and regularly measure progress, resolving issues as appropriate; drive overall team development and performance across R&D and/or Manufacturing.
  • Encourages employee base to create solutions and supports the execution, delegates appropriately.
  • Understand and influence a wide range of stakeholders; collaborate effectively across external customers and internal functional teams and business units to generate strong engagement and passionate advocates; think holistically and understand the impact of one’s own actions on people and other areas of the business; share insights and best practices; communicates effectively.

Qualifications:

  • BS in Chemistry, Management, Supply Chain and/or Industrial Engineering
  • Minimum 2-5 years of QA/QC experience in pharma, chemical, manufacturing, and/or R&D industries where cGMP/ICH/highly regulated facilities exist and are managed as such
  • Thorough expertise on ISO 9001, cGMP, ICH Q7, QMS in pharma or chemical regulated environments.
  • Strong communication, negotiation, and conflict resolution skills
  • Project management proficiency
  • Problem solving and root cause analysis passion
  • ISO 9001 Internal Auditor training a plus
  • Six Sigma Black Belt a plus
  • Green Belt in Lean Six Sigma with ASQ Certification a plus
  • Innovation training and experience a plus