drjobs QA Specialist

QA Specialist

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1 Vacancy
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Job Location drjobs

Morrisville, NC - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

JOB DESCRIPTION:

The role will require presence onsite at the Morrisville location and on 223 shift to support GMP operations. This is an alternating shift that includes weekends on a rotating basis as the manufacturing process is a 7day 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 teams 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: Bachelors Degree

Employment Type

Full Time

Company Industry

About Company

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