Job Description
Summary:
The Quality Assurance Inspector is responsible for to ensure adherence to company quality standards.
Essential Job Functions:
- Carries out responsibilities in accordance with the organization policies, procedures, and state, federal and local laws.
- Performs inspections of printed packaging components.
- Performs inspections of packaging components.
- Creates, revises and maintains specifications and methods of printed packaging components and packaging components.
- Ensures printed packaging components and packaging components are inspected, tested, and released in accordance with applicable FDA guidelines, regulations and internal SOPs.
- Creates status labeling activities (Released, hold) for printed packaging components and packaging components.
- Ensure that all printed packaging components and packaging components have been released prior to use.
- Inspects in-process production by confirming specifications, conducting visual and measurement tests, communicating required adjustments to production supervisor.
- Documents inspection and test results by completing reports, batch record pages, logs and all forms related to printed packaging components and packaging components.
- Ensure inspection activities are being performed by SOPs and cGMPs including but not limited to inspection, sampling and release of printed material and all other packaging components.
- Maintains inventory of all Printed Packaging components
- Maintain retain sampling program and room
- Ensure printed material (includes labeling) comply with component specifications/drawings/ master sample (or artwork). Including but not limited to label count, verification of barcode and artwork.
- Process /review documentation for accuracy and compliance with Good Documentation Practices
- Periodically review logbooks for accuracy and cGMP compliance
- Sample collection
- Maintains safe and healthy work environment by following standards, procedures and policies and complying with legal regulations.
- Performs Sampling of printed packaging components and packaging components.
Knowledge of:
- Documenting/Recording information – entering, transcribing, recording, storing or maintaining information in written or electronic format.
- Getting Information – Observing, receiving and otherwise obtaining information from all relevant sources.
- Inspection – Inspecting equipment, structures or materials to identify the cause of errors or other problems or defects.
- Communication – Communicates with supervisors, peers or subordinates providing information to by phone, in written form, email or in person.
Skilled in:
- Following all Good Documentation Practices and cGMP to ensure compliance to applicable FDA guidelines.
- Ability to follow a variety of instructions furnished in written, oral, diagram or schedule format.
- Meticulous and methodical, with excellent attention to detail.
- Strong organizational skills.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
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Job Requirements:
- Employee must be honest and ethical.
- Job requires being reliable, responsible, and dependable and fulfilling obligations.
Qualifications:
- Associate Degree or higher preferred
- 1 year of experience in manufacturing preferred
- 2 years of experience in GMP environment preferred
- 2 years of experience in Quality Assurance preferred
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