Job Description

Key Responsibilities:

Report Authoring:

• Pre-populate tables (including deviation tables) and graphs for PMRs.
• Manage and prepare data, compute statistical control limits, and assist with authoring reports related to process control and monitoring.
• Populate graphs, tables, and attachments into Word templates for CPV reports.

Report Verification:

• Verify raw data, figures, and tables; re-run charts and statistical analyses, ensuring alignment with original data sources and metadata.
• Check control limits, table formats, statistical summaries, and deviations against source data for PMRs and APRs.
• Reproduce CPV statistical outputs using JMP scripts and review for data accuracy.

Data Management:

• Extract and transform data from Excel or databases as needed.
• Perform data verification according to the client’s SOP, ensuring corrections are made before approval.
• Use QMS to identify deviations and complete necessary sign-offs.

Process Monitoring Meetings:

• Prepare data and generate outputs from JMP scripts for cross-site comparison.
• Update slide decks and attend bi-monthly Process Monitoring Tier 4 meetings.
• Take meeting minutes and track report progress during meetings.

Qualifications:

• Education:
• BS degree with 5 years or MS degree with 3 years of technical experience in biologics/biopharma or high-tech industry.
• Degree in Data Analytics, Data Science, Applied Statistics, or Applied Math preferred.
• Skills & Experience:
• Proficient in SQL, SAS, or equivalent for data extraction and transcription.
• Proficient in JMP, SAS, or equivalent for statistical analysis and familiar with Statistical Quality Control techniques, including SPC and Process Capability.
• Knowledge of Python for report generation is a plus.
• Proficient in Microsoft Word and Excel.
• Strong attention to detail with the ability to meet tight deadlines.
• Excellent communication, documentation, and project management skills.
• Ability to network and interact with teams across global manufacturing sites.
• Experience with Quality Management Systems (QMS) in the biotech industry.

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