Quality Assurance Inspector

Job DescriptionJob Description

Job Description

The Quality Assurance Inspector is responsible for auditing products and processes in all areas of operations such as production, packaging warehouse or document control to ensure adherence to company quality standards.

2nd Shift position - 3:30pm - 12:30am

Essential Job Functions:

· Carries out responsibilities in accordance with the organization policies, procedures, and state, federal and local laws.

· Performs visual inspection of in-process and finished product.

· Ensures that products are manufactured, tested and released in accordance to applicable FDA guidelines, regulations and internal SOPs.

· Assists with manufacturing floor activities (room clearance, in-process testing, AQL testing, product inspections batch record review, etc.)

· Assists in status labeling activities (raw materials, in-process, finished product)

· Ensure that all 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 results by completing reports, batch record pages, logs and input data from batch records into data logs.

· 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 components.

· Review cGMP records for accuracy and thoroughness prior to batch record submission

· Maintain retain sampling program and room

· Deliver stability samples to the QC laboratory or designated area.

· 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

· Sample blends and raw materials

· Process /review documentation for accuracy and compliance with Good Documentation Practices

· Periodically review logbook for accuracy and cGMP compliance

· Perform verification of manufacturing/packaging operations

· Perform Batch calculations

· Sample collection

· Maintains safe and healthy work environment by following standards, procedures and policies and complying with legal regulations.

· Reviews Batch Master Records throughout the process.

· Performs Sampling of sampling of active and inactive raw materials and packaging components

· Other job duties as assigned.

 

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.

 

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

Company DescriptionOxford’s mission is to provide affordable, high quality generic drug products to improve the lives of patients.Company DescriptionOxford’s mission is to provide affordable, high quality generic drug products to improve the lives of patients.

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