Pharmaceutical Qc Data Reporting Analyst

Job Description
Ability to work independently and as part of a team in a fast-paced, client facing environment.
Self-motivated, adaptable, and a positive attitude
Excellent communication (oral and written) and attention to detail
Compile internally and externally generated data in support of compiling CofAs and SofAs.
Prepare and provide CofAs and SofAs for all lot release materials
Work with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.
Trend QC product release data to support lot release and regulatory filings
Provide trending analyses to support various activities such as manufacturing investigations, and validation studies.
Assist in the implementation and maintenance of product release and stability data trending program for each product candidate
Prepare product annual release and stability data trending reports
Prepare monthly release data trending reports or as required
Perform reference standard trending
Perform trending of relevant systems suitability parameters
Prepare stability trend reports
Prepare and populate matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
Compile data to support QC department metrics and performance tracking
Assist with the improvement effort of streamlining the review and release process
Ensures compliance with applicable cGMP regulations and SOPs
Meet specified timelines to support release and regulatory filings
Complies with all pertinent regulatory agency requirements.
Participates in required training activities.