Job Description

GENERAL SUMMARY: 

Performs inspection and release of manufacturing goods during the manufacturing process by conducting routine and non-routine verification and review of in-process and finished products under general supervision and according to Quality Test Procedures (QTP) & Standard Operation Procedures (SOPs). Compiles data for documentation of test procedures and may assist with report preparation.  

PRIMARY DUTIES & RESPONSIBILITIES:

•Performs In-process, Final Inspection and Final Approval of Product:

oReviews and approves manufacturing Design History Records (DHRs), associated test reports and records and reports abnormalities.

oVerifies training and other records for compliance to specifications. 

oAssists with resolving non-conformances occurring with in-process and finished products.

oProvides quality oversight of manufacturing process/final packaging.

oUpdates departmental spreadsheets and statistics.

oAssists in revising DHR’s, work instructions, SOPs, etc.

oMaintains department documentation and inventory of retained materials. 

oReviews and approves manufacturing records such as test reports and 5S log-sheets.

•Assists with calibration/preventive maintenance (PM) program:

oChecks PM logbooks on manufacturing equipment for completeness and accuracy.

oVerifies area equipment is within calibration specifications.

•May assist with Incoming Inspections as required.

•Assists with Internal audits and participates in 3rd party audits.

• Confirms completion of required training plan before assuming job responsibilities.

•Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

•Performs other assignments or projects as directed.

REQUIRED QUALIFICATIONS: 

1.Knowledge, skills & abilities:

•Deep understanding of GMP regulations and Process Controls, including document review, in-process and final acceptance criteria, identification and traceability requirements, and segregation of materials.

•Able to effectively share information and ideas within and outside of department in written or verbal form; able to put forth own ideas and gain understanding from others.

•Able to at support effective interactions between team members and among cross-functional teams.

•Proficient experience with MS Office suite (Word, Excel, Outlook).

2Minimum certifications/educational level:

•Associate’s degree or combination of education and applicable job experience. 

•Bachelor’s degree preferred.

3.Minimum experience:

•2 years’ relevant quality and/or manufacturing experience in a FDA regulated industry, preferably medical devices

•Experience with QSRs, QC testing methods and general knowledge of GMP requirements for production. 

•Experience with lot release, document review, and in-process inspection.