QCM Data Reviewer II

Core Hours: Monday-Friday, 7am-330pm

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 review and verify accuracy and completeness of microbiological data generated in the laboratory. Data including results of in-process, raw materials and final drug product testing.
• Perform data review to ensure compliance with test methods, work instructions, compendia, and other standard operating procedures.
• Perform review and verify accuracy and completeness of environmental monitoring data from sampling performed in manufacturing.
• Evaluate testing results and data against relevant specifications, protocols, and testing 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.
• 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.
• Perform routine calculations.
• Communicate with management to proactively address the quality of laboratory documentation.
• Attend required company and department meetings.
• Complete required training activities within required timeframes.
• Foster 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

• Familiarity with the operation of laboratory equipment such as balances, hoods, water baths, pH meters, and autoclaves.
• Understanding of LIMS (Laboratory Information Management system) and MODA (Mobile Data Acquisition for Environment and Utilities Monitoring)
• 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 microbiology laboratory techniques.
• Effective written and oral communication skills.
• Experience with the use of electronic document management system(s).
• Experience with the use of a LIMS and/or MODA 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.

Core Values

• The QCM 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.

Education & Experience

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

Working Conditions

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

Compensation and Benefits

• Pay: $32.00 - $34.00 per hour depending on experience
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.