Requisition ID 15456BR
Title Sr. QA Aseptic ProcessingArea Specialist
Job Category Quality
Job Description Position Purpose:
Collaborate with the Aseptic Production department in facilitating improvements initiatives in aseptic conduct and technique. Perform aseptic process assessments of aseptic conduct and technique. Serve as an expert in the quality department on aseptic conduct and technique. Provide support for the environmental monitoring, media fill and classification programs in the facility. Participate in review meetings for the disposition of environmental monitoring non conformities to ensure compliance with site, corporate and regulatory expectations. Perform quality reviews and approvals of documentation including change request documents, specifications, validation protocols, non-conformity investigations, procedures, etc.
Education: BS in science related discipline
Experience: Minimum of 7 years of experience in one of the following areas: aseptic processing processes, microbiology or related technical discipline including a minimum of 1 years of experience in a quality related function. Must have ability to apply aseptic processing knowledge to pharmaceutical applications and a good quality mindset.
Physical Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified.Ability to work in loud noise environments.
Ability to work hours necessary to support production and /or maintenance activities.
Technical/Process/Functional Knowledge: Knowledgeable in the following systems: Filling and Formulation.
Desired knowledge in Utilities, Inspection, Wash and Sterilization processes
Department QA Aseptic Production
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Sr. QA Aseptic ProcessingArea Specialist
Job Category Quality
Job Description Position Purpose:
Collaborate with the Aseptic Production department in facilitating improvements initiatives in aseptic conduct and technique. Perform aseptic process assessments of aseptic conduct and technique. Serve as an expert in the quality department on aseptic conduct and technique. Provide support for the environmental monitoring, media fill and classification programs in the facility. Participate in review meetings for the disposition of environmental monitoring non conformities to ensure compliance with site, corporate and regulatory expectations. Perform quality reviews and approvals of documentation including change request documents, specifications, validation protocols, non-conformity investigations, procedures, etc.
Education: BS in science related discipline
Experience: Minimum of 7 years of experience in one of the following areas: aseptic processing processes, microbiology or related technical discipline including a minimum of 1 years of experience in a quality related function. Must have ability to apply aseptic processing knowledge to pharmaceutical applications and a good quality mindset.
Physical Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified.Ability to work in loud noise environments.
Ability to work hours necessary to support production and /or maintenance activities.
Technical/Process/Functional Knowledge: Knowledgeable in the following systems: Filling and Formulation.
Desired knowledge in Utilities, Inspection, Wash and Sterilization processes
Department QA Aseptic Production
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%