QC Data Reviewer II (2nd Shift)

• Training Hours may vary 

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.

• →Perform data review to ensure compliance with published methods, work instructions, compendia, and other standard operating procedures.
• →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.
• →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 found.
• →Generate standard forms for testing to ensure consistency across all types of testing.
• →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.
• →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.
• →Foster cooperation and teamwork among staff.
• →Following policies, protocols, and standard operating procedures.
• →Ensure testing per deviations and laboratory investigations was followed.
• →Participate in laboratory process improvement initiatives such as lean lab principles, implementation of electronic laboratory notebooks and ERP systems.
• →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

• Experienced 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.
• 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.

• The QC Data Reviewer II is expected to operate within the framework of Tolmar’s Core Values:
  • Center on People:  We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
  • Are Proactive & Agile:  We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
  • Act Ethically:  We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
  • Constantly Improve:  We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
  • Are Accountable:  We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

• Bachelor’s Degree in science or related field.
• Two or more years of analytical laboratory experience and/or data review in a pharmaceutical environment.

• Laboratory setting: may be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceutical substances.
• Office setting.