QC Data Reviewer III

Core Hours: Monday - Friday, 7am-4pm 

Purpose and Scope

Perform data review to ensure the quality of laboratory data is maintained in accordance with the highest standards. Ensure that all data generated is documented according to cGMP and ALCOA+, and maintain data integrity.  Data review will encompass review against all applicable methods, work instructions and standard operating procedures.

Essential Duties & Responsibilities

• Perform data review to ensure compliance with published methods, work instructions, compendia, and other standard operating procedures.
• Train and develop new data reviewers teaching them proper cGMP principles and proper documentation practices.
• Lead laboratory process improvement initiatives such as lean lab principles, implementation of electronic laboratory notebooks and ERP systems.
• Lead the process for generation of standard forms for testing to ensure consistency across all types of testing.
• Evaluate testing results and data against relevant specifications and suitability requirements.
• Ensure that all data generated follows the principles of ALCOA + and recognize discrepancies related to testing documentation.
• Perform review of logbooks, materials, equipment calibration and instrument settings.
• Perform critical reviews of protocols, reports, quality events, method and procedure updates.
• Review all applicable data printouts including, titration and other wet chemistry printouts, chromatography, integration and sequences.
• Review and approve all audit trails and any associated metadata applicable to the testing and data generated. Work to resolve any discrepancies that are discovered.
• Perform routine calculations.
• Review daily verifications generated in the laboratory.
• Review and approve sample submission paperwork.
• Authorize all sample data in the notebook as well as the associated data repositories (Endeavor and LIMS).
• Perform review of chemist reports generated in the laboratory.
• Assist the QC trainers by updating all QC training matrices.
• Attend required company and department meetings.
• Complete required training activities within required timeframes.
• Assist with training of other analysts and reviewers.
• Assist with review and preparation of standard operating procedures and training documents.
• Lead cooperation and teamwork among staff.
• Following policies, protocols, and standard operating procedures.
• Ensure testing per deviations and laboratory investigations was followed.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Responsible for daily activities and supervising staff that are hazardous waste generators and/or handlers. Respond to spills according to the Chemical Spill Response procedure.
• Perform other duties as assigned.

Knowledge, Skills & Abilities 

Knowledge

• Vast Experience in the operation of analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-Vis spectrophotometry, TLC, Karl Fischer titration, rheometry.
• Experience with sample preparation from a variety of matrices.
• Strong working understanding of FDA regulations, USP, NF, ICH, EP, and other pertinent compendia.
• Experience in the accurate review of laboratory testing data.

Skills

• Experience with laboratory and wet chemistry techniques (e.g. weighing, volumetric glassware, titrations, etc.).
• Effective written and oral communication skills.
• Experience with the use of electronic document management system(s).
• Experience with the use of a LIMS system preferred.
• Experience with the use of word processing, spreadsheet, and database programs, including MS Office.
• Experience with computer systems for sample tracking, laboratory equipment, and raw data handling.

Abilities

• Ability to learn and apply new techniques.
• Attention to detail. Accurate and consistent in data compilation and review.
• Ability to work independently, with other analysts, and handle multiple projects and timelines concurrently.
• Ability to identify process inefficiencies and correct them.
• Experience with electronic notebook administration a plus.

Core Values

• The QC Data Reviewer III is expected to operate within the framework of Tolmar’s Core Values:
  • Center on People: