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IT Compliance Analyst

2 months ago

Signal Hill, California, United States Sapta Global Inc Full time
Job Description

Position Overview:
Join a dynamic team at Sapta Global Inc, where we are committed to delivering innovative healthcare solutions. We are currently seeking an IT Quality Assurance Analyst to support our operations in the biopharmaceutical sector. This role offers a unique opportunity to gain extensive experience in Bulk Drug Substance manufacturing.

The IT Quality Assurance Analyst will be responsible for providing oversight and support for Quality Assurance processes, ensuring compliance with industry standards and regulations. This position will involve working closely with Contract Manufacturing Organizations (CMOs) to manage quality oversight, including change management, deviation management, and product release.

Key Responsibilities:
1. Oversee CMO Batch Production Records and review executed Batch Records and GMP documents for product release.
2. Assist with Document Control and other Quality Assurance functions.
3. Coordinate timely reviews of documentation associated with manufacturing at CMO sites.
4. Prepare for regulatory audits and inspections, providing daily summaries and tracking the completion of corrective actions from audit findings.
5. Provide guidance to CMOs to ensure compliance with Client Quality standards and resolve any audit items.
6. Review Quality Events and CAPAs from audits to ensure timely completion of necessary actions.

Qualifications:
1. Bachelor’s degree in Life Sciences or a related field with a minimum of 5 years of relevant experience in the pharmaceutical or biotechnology industry.
2. Hands-on experience in Quality Assurance, including supporting validations within the pharmaceutical or biotechnology sector.
3. Familiarity with cGMP Quality, Quality Systems, and Biopharma Production Processes is preferred.
4. Strong communication skills and the ability to work collaboratively with various teams.
5. Detail-oriented with a keen ability to identify errors in documentation.

Job Type: Contract
Salary: $40 - $45 per hour
Schedule: 8-hour shift