QC Analyst II (Onsite) - 1st Shift (Tuesday - Saturday)

Purpose and Scope

Performs routine testing of raw materials, cleaning samples, bulk intermediate and finished product, and/or stability samples, according to established regulatory protocols and procedures.

Essential Duties & Responsibilities

• Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods.
• Train junior analysts in analysis methods and lab techniques.
• Document all activities and maintain records according to good documentation practices.
• Perform intermediate method transfers.
• Provide detailed accounts of testing performed to investigators.
• Under the direction of management, make scientific recommendations to management/technical writers regarding QC procedures.
• Complete tasks on time and work to eliminate repeat errors.
• Follow all procedures applicable to job functions to ensure high quality of work.
• Prioritize tasks and perform job duties with minimal guidance from management.
• Work to complete tasks in an efficient manner, and be a productive member of the department.
• Ensure that company and regulatory data integrity guidelines are consistently followed.
• Contribute to a highly productive environment by avoiding distractions.
• Avoid distractions and assist co-workers in the completion of tasks.
• Represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary.
• Interact respectfully with all other employees both inside and outside of the department and members of management, and show interest in others' input and reasoning.
• Identify issues and escalate those issues to the department senior leadership or management as appropriate.
• Support the department leadership with the implementation of new systems, and continuous improvement efforts.
• Generate new ideas to create efficiencies and improve processes; willingly support new ideas and process enhancements.
• Participate in required annual hazardous waste training.
• Respond to spills per the Chemical Spill Procedures.
• Perform additional duties as assigned.

Knowledge, Skills & Abilities

• Knowledge of a government regulated laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
• Intermediate understanding of the use of USP, NF and other compendia.
• Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.
• Effective written and oral communication skills.
• Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Ability to interpret, understand and follow analytical procedures/calculations and scientific principles.

Core Values

• Center on People: Support the well-being of patients and treat employees and those served as valued partners.
• Proactive & Agile: Embody a culture of engagement and action, adapt to change, respond swiftly and efficiently.
• Act Ethically: Conduct business ethically, comply with laws, and foster diversity, equity, inclusion & sustainability.
• Constantly Improve: Enhance products, systems, processes, and services through innovation, calculated risk-taking, and quality improvements.
• Accountable: Be honest, transparent, and clear in alignment with core values, take responsibility for work, actions, successes, and setbacks.

Education & Experience

• Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Two or more years of experience in an analytical laboratory position.

Compensation And Benefits

Pay: $36.00 - $37.00 per hour, depending on experience.
Shift Differential: 10% after training period
Benefits summary: https://www.tolmar.com/careers/employee-benefits