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Job Summary

This position will have direct responsibility and accountability for all phases of the documentation and data review process. This position is also responsible for QC systems which include but are not limited to QC inspection/audit management, QC equipment qualification/software validation, compendial monitoring/regulatory surveillance, QC document lifecycle management, and QC quality systems management. This position requires operational thinking to keep all projects on schedule and up to date.

Responsibilities

• Manage the timely review of QC data processes to ensure data integrity and compliance with company SOPs and specifications, audit data packages for both scientific merit and GDP
• Manage the data reviewers in QC Documentation Compliance group in their daily assignments to ensure review of relevant QC data and corresponding documentation are completed within expected timelines
• Manage the verification of data transfer, calculations, and documented information such as reagent expiry, instrument calibration, logbook entries, standards, controls, etc.
• Compile and file QC data packages and reports in both paper and electronic formats
• Ensure monthly logbook audits are successfully conducted
• Manage compliance related activities related to both internal and external audits
• Conduct periodic informal laboratory audits to ensure inspection readiness of the labs
• Participate in addressing internal and external audit findings within defined timeframe
• Manage inspection readiness program with guidance from QC leadership team

• Verify that all analysis performed are as per test method and/or compendial methods, and are compliant with GMP requirements
• Manage compendial monitoring and regulatory surveillance program for updates relevant to QC and propose appropriate action
• Ensure lab investigation related to QC testing, root cause analysis, and deviation reporting, etc. are compliant and completed within the required timeframe
• Generate new and /or revise existing department-related SOPs. Track periodic assessment of SOPs to ensure revisions occur on time and represent current compliant procedures
• Oversee QC document lifecycle management of QC SOPs, work instructions, test methods, specifications, etc.
• Complete training for QC systems SOPs in timely manner
• Oversee QC quality systems management of LIRs, deviations/NCRs, change controls, CAPAs, etc.
• Utilize knowledge of good documentation practices and good laboratory practices on a daily basis
• Other duties as assigned

Skills Required

• Well-organized, capable of multi-tasking, and able to collaborate with individuals in a matrix environment
• Able to maintain detailed and accurate records
• Excellent communication written and oral skills
• Motivated and flexible to work in a dynamic group
• Must work with a balance of both speed and accuracy
• Capable of working independently
• Ability to remember and accurately follow detailed instructions
• Experience with computer software such as WORD, EXCEL, etc.

Education and Experience

• BS degree in scientific area or equivalent
• 5-7 years of data review experience
• 8+ years of pharmaceutical experience
• Knowledgeable in FDA Guidance, ICH Guidelines, and ISO certifications
• QA experience reviewing documentation preferred
• Advanced knowledge of analytical methods and testing using QC related instrumentation
• Advanced knowledge of GMPs, safety regulations and data integrity
• Experience in Health Authority inspections a plus
• Prior managerial or lead experience preferred

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Compensation:

The base salary for this role starts at $161,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.