Sr Associate Supplier Quality (31367) – Juncos, PR

Master’s degree OR Bachelor’s degree & 2 years of Quality or Operations experience

Educational background in Science or Engineer

 

Experience in areas such as:

Raw materials

Document management review/approval follow up

Communication skills

Negotiation skills

Supplier/service providers management

 

Description

Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at site. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

 

FUNCTIONS

  1. Subject Matter Expert advocate for raw material supplier quality issues and initiatives
  2. Work on projects to drive continuous improvement activities for raw material processes across functions and sites
  3. Work to resolve supplier issues
  4. Develop, revise, and implement raw material specifications and procedures that comply with regulatory requirements
  5. Participate in raw material qualification, raw material commercialization, and second sourcing efforts
  6. Perform supplier and material risk assessments
  7. Willing to travel** Other functions may be assigned.

 

EDUCATION

Master’s degree OR Bachelor’s degree & 2 years of Quality or Operations experience.

 

PREFERRED QUALIFICATIONS

  • A./B.S. Biological Sciences/Life Sciences or related field or the equivalent combination of education and/or experience
  • 2 + years in Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in raw materials, auditing, investigations, and/or change control.
  • Previous experience in Supplier Quality Management
  • Previous supplier auditing experience
  • Ability to interact with regulatory agencies
  • Working knowledge of major pharmacopeias. Emphasis in Excipient Elemental Impurities
  • Experience with executing risk assessments using various risk tool (FMEA, PrHA etc.)
  • Strong written and verbal communication skills
  • Ability to interpret and apply compliance and quality requirements (FDA, EME, ICH etc.)
  • Ability to work independently as well as on teams
  • Ability to prioritize and manage multiple tasks, including multiple assignments and processes
  • Ability to work efficiently and effectively in a challenging and fast-paced work environment
  • Create procedures and processes to drive desired results
  • Proficient project management skills
  • Apply analytical skills to evaluated and interpret complex situations/problems
  • Works under minimal direction
  • Independently develops solutions that are thorough, practical, and consistent with functional objectives
  • Extends capabilities by working closely with senior staff/experts within and outside the internal organization
  • Broad technical knowledge of raw materials, testing and specification generation
  • Can serve as a topic expert and resource to others
  • Experience in working with and/or knowledge of how raw materials are used in client’s manufacturing processes

 

1st SHIFT