Description:
As a Documentation Specialist 1 you will:
- Responsible for quality oversight and assistance with Inspection/Packaging processes at the Client Grand Island Manufacturing Facility.
- Position is also responsible for AQL sampling and AQL related product inspection.
- Position recommends corrective action in response to deviations noted and assures compliance to SOPs and cGMPs while following and reviewing Good Documentation Practices.
- Performs visual inspection of samples by utilizing AQL sampling of product following visual inspection and labeling/packaging for all product vial sizes and types.
- Recognizes opportunity for improvement and compliance and immediately communicates them to production colleagues and MQA Supervision.
- Must obtain and maintain Visual Inspector qualification for performing AQLs; subject to on-going qualification training/testing.
- Assures proper line clearances and quality assurance procedures are followed within the Inspection and Packaging areas.
- Assures that the packaged product meets best quality standards.
- Becomes the cGMP “go to person" on the Inspection/Packaging floor.
- Reviews batch record pages and makes sure proper documentation and on-line completion.
- Verifies completion of line clearances when necessary.
- Responsible for complying with all SOPs and cGMPs.
- Responsible to see that all operations on the Inspection/Packaging floor are being performed as required by written procedures.
- Assured critical steps have been performed as directed in SOPs and batch records.
- Assures a safe working environment and always wears appropriate safety equipment/apparel as well as alerting the supervisor to unsafe conditions in the department.
- Performs other duties as assigned and works overtime as needed.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities
The Ideal Candidate will have:
- Visual inspection experience, QA experience, Microsoft program experience.
- Minimum of High School Diploma/GED with 1-3 years of experience / bachelor’s degree in Life Sciences or related field.
- Broad production knowledge a plus.
- Work in Pharma Desired.