Qc Specialist Ii (Data Review)

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Job Description

QC Specialist II (Data Review)

The successful candidate will fully understand GMP, GDP, Data Integrity, and Quality Control. This role will have responsibility for the data review generated by CxO's to support product release. The candidate will partner with internal and external partners to source, monitor, and manage CxO data as it related to product release.

Job Responsibilities

• Efficient and thorough review of cGMP data associated with testing of commercial product release, stability, critical reagent qualifications and test method qualifications, validation and transfer generated by Contract Testing Laboratories (CTLs)
• Ensure timelines for data review are met in support of batch release and product supply
• Ensures that standards for documentation comply with SOPs, protocols, analytical methods, Good Documentation Practices (GDP) and industry standards.
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards.
• Review laboratory logbooks, data packages, labeling and other documentation to ensure compliance with SOPs and industry guidelines.
• Reviews raw data, protocols, reports, and certificates of analysis.
• Compile and summarize QC raw data in various physical and electronic report formats.
• Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute test data review.
• Participates in compliance-focused teams working towards the goal of continuous improvement of procedures and practices.
• Coordinate and track progress of analytical testing at CTLs
• Support Change Controls, Laboratory Investigations, Deviations and CAPAs
• Participate in regulatory agency audits and inspections

Knowledge & Skills

• Exceptional attention to detail in documentation, good organizational and time management skills.
• Excellent oral and written communication for effective interpersonal collaboration with the ability to multitask/prioritize while working under restrictive timelines.
• Ability to work in a highly regulated (commercial GMP) team environment and perform job responsibilities with minimal supervision.

Education & Experience

• 4+ years of experience with Bachelor's degree in a relevant scientific discipline OR 2+ years of experience with Master's degree in a relevant scientific discipline.

• Sufficient knowledge to recognize issues with data integrity, GDP errors, out of specifications (OOS), out of trends (OOT) and adverse results.
• Experience with the following assays is a plus: CE-SDS, Cell Binding, Protein ID, Cytotoxicity, ELISA, HPLC/UPLC, CEX, Bioburden, Endotoxin, pH, appearance, and osmolality.
• Strong familiarity with Good Manufacturing Practices (GMPs), 21 CFR, Data Integrity and ALCOA principles.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.