Specialist / Senior Specialist - QA Raw materials / Supply Chain

Job content

Job Summary

The Specialist / Senior Specialist – QA Raw Materials/Supply Chain is an individual who will serve as the lead associate responsible for supervising sampling, coordination and QA release of raw materials and consumables for new development biopharmaceutical manufacturing facility as well as subsequent cGMP manufacturing operations.

Job Responsibilities

• Execute daily activities to assure timely inspection, sampling and release of raw materials and consumables in collaboration with manufacturing and supply chain. Assists in execution and maintenance of the raw materials / consumables retain program, client cell banks and client drug substance retain program.
• Support relevant investigations, change controls, CAPAs and raw material / consumable related projects. The individual provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.
• Review and disposition of raw materials and consumables used for cGMP manufacturing. Assures activities comply with required procedures and cGMP requirements.
• Prepares cGMP documentation for sampling, testing and disposition of raw materials and consumables, including documentation for testing by approved external contract laboratories. Tracks status of samples, receives test results from contract laboratories and compiles documentation for final disposition. Enters documentation and necessary information to complete QA disposition transactions in the inventory management system.
• Support the management of raw material / consumables retain program, client cell bank inventories and bulk drug substance retains.
• Maintains raw material sampling areas and equipment to required cleanliness classification and cGMP state. This includes execution of routine cleaning, non-routine cleaning and GMP audits.
• Support QA functional areas, manufacturing, and supply chain on material / consumable needs in support of manufacturing batch release and project timelines. Assist all training activities of associates that are related to the functionality of the QA Incoming Raw Material Release Department.
• Support Supply chain activities from QA perspective.
• Attends relevant operational meetings in support of Manufacturing operations and material / consumable disposition activities. Other activities as assigned by Management. Attend daily manufacturing forecast and release meetings.
• Collaborate with manufacturing, supply chain and other internal stakeholders as needed to achieve site, operational and department goals.
• Cultivate and maintain Quality culture.
  
  

Job Requirements

• Master, BS degree or relevant CFC completed and two years of experience or one year of experience in a QA cGMP regulated environment within the Biopharmaceutical industry.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Experience in QA inspection / release of materials for cGMP / commercial or development manufacturing, Quality Control and raw materials is beneficial.
• Knowledge of US and EU cGMP requirements is necessary.
• Ability to read, analyze, and interpret, general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Fluent in French and English.
  
  

KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.