Job Description

JOB PURPOSE: 

The Quality Assurance Associate I works as an integral part of the Quality Assurance team.  The primary responsibilities of this position is to assist with document control, records management and review of manufacturing batch records.  The Quality Assurance Associate will keep files and documents organized, working with both paper and electronic records. The Quality Assurance Associate will help maintain the Quality Assurance document control system, while making sure documents are stored and labeled appropriately. 

JOB DUTIES: 

·       Issuance and review of Manufacturing Batch Records

·       Issuance of Deviation/Non- Conformance and CAPA numbers

·       Organize and file current documents per the company’s current filing process

·       Receive, track and file-controlled documents, such as monthly LUMAC logs, batch records, Quality Control testing logs, training records etc.

·       Receive and manage incoming materials

·       Assist team in scanning, organizing, and indexing critical documentation

·       Be proactive in informing the team members of documents in jeopardy of being late

·       Databases and paper filing need organization to work correctly.  Correct, accurate filing is essential for future retrieval of records

·       Support Quality Team members with other duties, such as the audit program, training program, outgoing and batch release processes

SKILLS/ QUALIFICATIONS:

·       Experience in a Good Manufacturing Practice (GMP) is preferred but not required 

·       Proven ability to work in a fast-paced environment/high pressure environment

·       Excellent organizational skills and attention to detail

·       Team player with excellent interpersonal, verbal and written communication skills

·       Good working knowledge of MS office applications, computer proficiency

·       Comfortable in responding to questions from various managers

·       Demonstrate skills to plan, organize, analyze, and resolve problems

EDUCATION/ EXPERIENCE:

·       Bachelor’s degree in life sciences, pharmaceutical, biotech or related fields and 0 to 1 year working knowledge of FDA requirements and cGMP documentation in a regulated biotechnology or pharmaceutical environment. OR Associate degree in life sciences, pharmaceutical, biotech or related fields and 1- 2 years working knowledge of FDA requirements and cGMP documentation in a regulated biotechnology or pharmaceutical environment.

Company Description

Celltex is best known as a pioneer in the field of regenerative medicine by making cultured stem cell products available to provide a different solution to your quality of life. As the premier provider of adult, autologous mesenchymal stem cell (MSC) technology in North America, Celltex can do what no one else can: isolate, cryopreserve and grow hundreds of millions of one's own genetically stable MSCs in our FDA-registered lab for therapeutic use from a simple one-time adipose tissue extraction. Celltex continues to make innovative and technological advances through its GMP manufacturing of MSCs for clinical phases of cell therapy. Celltex is looking to hire a quality professional with experience and knowledge in the cell therapy and biotechnology industry to ensure optimal product quality.