Senior Quality Assurance Inspector - 2nd Shift

Operations; Town of Brookhaven (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Operations in the Town of Brookhaven area seeks a QA Inspector II to monitor sampling, testing, and labeling compliance across manufacturing processes. You will review batch records, calibration logs, pest control records, and contractor functions to ensure GMP compliance before, during, and after packaging runs.

Strong collaboration with manufacturing is essential. Requires at least 3 years in QA and a high school diploma or GED.

Qualifications

• 3+ years in QA or related field

Responsibilities

• Monitor and sample incoming materials, packaging components and returned goods for compliance.
• Ensure compliance of all drug manufacturing phases with established specifications.
• Receive, inspect, release and control labels and outserts.
• Ensure quality compliance before, during and after each packaging run.
• Review engineering records and online batch records for signatures and reconciliation.
• Verify functionality of equipment and controls during batch runs.
• Maintain retention sample room and monitor temperature/humidity.
• Generate and proofread in-house labels per master batch records.
• Perform rinse and swab sampling for microbial verification.
• Handle complaint samples and batch records for investigations.
• Identify gaps in manufacturing/packaging equipment and assess impact.
• Coordinate with manufacturing and engineering to resolve compliance issues.
• Other duties as assigned.

Skills

QA

Inspection

Sampling

Documentation

GMP

Batch Records

Education

High School or GED - Required

Job description

Description:

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run.

Essential Functions:

• All requirements from Inspector II,Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)Review of online batch records in terms of completeness of signatures, entries, and actual reconcilaiton / yields prior to initiation of next processing stepVerification of functionality of all the equipment and associated controls during the batch runMaintenance of retention sample room and monitoring of temperature and humidity, replacement fo chart records as per schedule, review of log and disposition of samples. plus the following:

• Monitor and release of Purified Water System

• Generates, proof read and issues \"in-house\" labels as in accordance with Process Study protocols and master batch records.

• performs rinse and swab sampling for microbial cleaning verification

• Handling complaint samples, visual inspection or retention / complaints samples, Batch record review for the receipt of complaint batches, collection of complaints / retention samples for analytical testing in case of complaint investigation

• Identification of gaps in the manufacturing and packaging equipment and assess the impact on the quality of product

• Coordination with manufacturing and engineering teams to resolve compliance issues in a timely manner

Additional Responsibilities:

• Performs rinse and swab sampling for microbial cleaning verification

• Handling complaint samples, visual inspection or retention / complaints samples, Batch record review for the receipt of complaint batches, collection of complaints / retention samples for analytical testing in case of complaint investigation

• Identification of gaps in the manufacturing and packaging equipment and assess the impact on the quality of product

• Coordination with manufacturing and engineering teams to resolve compliance issues in a timely manner

• Other duties that management may from time to time assign.

Education:

• High School or GED - Required

Experience:

• 3 years or more in 3 or more years' experience in QA or related field