What are the responsibilities and job description for the QA Specialist position at Real Soft Inc?
Job Description
Job Description
JOB DESCRIPTION :
The role will require presence onsite at the Morrisville location and on 2-2-3 shift to support GMP operations. This is an alternating shift that includes weekends on a rotating basis, as the manufacturing process is a 7-day a week process. Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence. Responsible for performing inspection and disposition of raw materials and components by : Working within our ERP system (Slingshot) to ensure compliant material release. Acquiring Certificates from Vendors to support Release per Master Specification. Reviewing the required documentation (CoA, CoC, CoS, etc.) to ensure that the material meets testing specification. Ensure rejected and or released materials are transferred to the appropriate areas by collaborating with appropriate stakeholders. Upon release, archiving the completed Mater Specification within document control room. Proactively assess and identify risk for mitigation and communication to stakeholders. Responsible for completing assigned training and other tasks in a timely manner and representing Quality in meetings and providing meeting feedback to the team as required. As required, advise and provide quality oversight and compliance guidance based on the company procedures and standards for the SMPA Quality Management System. Responsible for completing the logbook and Work Order reviews for Manufacturing, Engineering, Quality, and Warehouse to ensure that the entries are complete and adhere to company policies and procedures. Responsible for providing QA review / approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
Skills : Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents. Relevant experience and knowledge of manufacturing, batch record review, and / or analytical analyses for the biotech / pharmaceutical industry. Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence. Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs. Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight. Working experience in KNEAT, SlingShot, Blue Mountain RAM and VEEVA is preferred. Education : B.S. in chemistry, biological or pharmaceutical sciences, or related discipline. At least 3 years of experience in the biotech / pharmaceutical industry within research and development or commercial organizations.
Required Skills : QA, Batch Record Review, Batch records, Shop Floor, CGMP
Additional Skills : Biotech / Pharmaceutical, Organization skills, ERP, Mitigation, Chemistry, Document Control, QMS, Control Room, Archiving, Operations, FDA, GMP, Documentation, Manufacturing Process.
Minimum Degree Required : Bachelor's Degree
