KBI Biopharma

Job Summary:

This individual will be responsible for compliant aseptic sampling, coordination and QA release of raw materials and consumables for clinical and commercial biopharmaceutical manufacturing facilities, as well as subsequent cGMP manufacturing operations. Executes daily activities to assure timely review of raw materials and consumables dispositioning paperwork in collaboration with Quality Control and supply chain. Assists in execution and maintenance of the raw materials / consumables retain program, client cell banks and client drug substance retain program. Maintains raw material sampling areas and locations in a compliant state. 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. Collaborates with manufacturing, supply chain and other internal stakeholders as needed to achieve site, operational and department goals. Cultivates and maintains Quality culture.

Job Responsibilities:

We are seeking an entry level QA Associate to join our team at a contract manufacturer for mammalian cell culture protein therapeutics. The primary responsibility of this role is to oversee the QA approval of Raw Materials and compliance of the Regional Warehouse. The position will have the following responsibilities:

• Reviewing receiving inspection records and removing holds in the warehouse management software to efficiently disposition raw material and consumable batches. The personnel will be required to collaborate between supply chain, quality control and manufacturing to help prioritization of disposition
• Assists in maintaining compliant sampling and receiving of raw materials and consumables used for cGMP manufacturing. Assures activities comply with required procedures and cGMP requirements.
• Support the management of raw material / consumables retain program, client cell bank inventories and bulk drug substance retains.

Minimum Requirements:

Knowledge / Education:

• High school diploma and two years of experience within the Biopharmaceutical industry or Bachelor's degree in a related field (e.g., Chemistry, Biology, Quality Assurance).
• 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 manufacturing, Quality Control and raw materials is beneficial

Language Ability:

• 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

Reasoning Ability:

• 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 Math Ability

Physical Demands:

• Ability to support manufacturing and warehouse operations to include movement and/or lifting of raw materials, consumables, cleaning materials and equipment.
• Ability to sit for long periods of time working at a computer workstation
• Pushing and pulling up to 30 pounds

Computer and Equipment Usage and Skills:

• Knowledge of and ability to use word processing, databases, spreadsheets, internet, email, calendar management, telephone

Range: $26.44 / hr. - $36.49 / hr.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.