Quality Data Reviewer – cGMP Lab (2nd Shift)

West Pharmaceutical Services, Inc; Cidra (PR); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Paid time off

Annual bonuses

Career development

Job summary

West Pharmaceutical Services, Inc. in Cidra, PR is seeking a Quality Technician to independently review analytical data and support post-production quality activities, including finished batch release and sterilization-related tasks.

You will maintain knowledge of current regulations and guidelines, use SAP for batch-related processes, and collaborate with Quality teams to ensure data integrity, documentation accuracy, and compliance with cGMP standards.

Qualifications

• High school diploma or GED required.
• Minimum 1+ year in cGMP environment utilizing SAP preferred.
• Basic to moderate understanding of English required.
• Read and interpret data, information, documents, and technical writing required.

Responsibilities

• Perform cGMP Data Review on the analytical data generated in Lab Operations which may include raw materials and finished goods, product performance, container closure integrity, particle analysis, and/or microscopy/investigation.
• Review the analytical raw data generated by laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP compliance.
• Review Electronic Data and Audit Trails for data integrity compliance.
• Review Lab Operations Methods, Protocols, and Work Instructions for cGMP Compliance.
• Responsible to review and approve of samples and/or batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing.
• Responsible to review and approve of relevant packaging and respective graphics artwork.
• Maintain working knowledge of computer software packages including MS Office suite, Adobe, MasterControl, LIMS, and LMS.
• Collaborate as needed on proposed path forward regarding documentation questions.
• Support preparations for periodical management reviews.
• Initiate processes in SAP as needed related to finished batch release and sterilization processes.

Skills

cGMP Data Review

Data integrity review

SAP

MS Office

LIMS

MasterControl

Adobe

Education

High school diploma or GED

Tools

SAP

MS Office

Adobe

MasterControl

LIMS

LMS

Job description

West Pharmaceutical Services, Inc. in Cidra, PR is seeking a Quality Technician to independently review analytical data and support post-production quality activities, including finished batch release and sterilization-related tasks.

You will maintain knowledge of current regulations and guidelines, use SAP for batch-related processes, and collaborate with Quality teams to ensure data integrity, documentation accuracy, and compliance with cGMP standards.