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

Core Hours: Tuesday - Saturday, 7:00 am - 3:30 pm. Training hours may vary.

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.

Responsibilities

• Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods.
• Train and become proficient in the intermediate preparation techniques and analysis methods.
• At the direction of management, train junior analysts in analysis methods and lab techniques.
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Accountable for proper use, care, and maintenance of instrumentation.
• Perform intermediate method transfers.
• Provide detailed accounts of testing performed to investigators.
• Under the direct supervision of an investigator, may perform investigational testing.
• Make scientific recommendations to management/technical writers regarding QC procedures.
• Completes tasks on time and works to eliminate repeat errors.
• Follows all procedures applicable to job functions to ensure high quality of work.
• Prioritizes tasks and performs job duties with minimal guidance from management.
• Works to complete tasks in an efficient manner and is a productive member of the department.
• Contributes to a highly productive environment by avoiding distractions.
• Ensures that company and regulatory data integrity guidelines are consistently followed.
• Maintains an atmosphere of teamwork, cordiality, and respect towards co-workers.
• Assists co-workers in the completion of tasks.
• Represents the department by providing accounts and results of method transfer activities and assists with troubleshooting aberrant method transfer results.
• Interacts respectfully with all other employees both inside and outside of the department and members of management.
• Appropriately resolves differences of opinion.
• Upon delegation, may represent the QC chemistry laboratory when communicating with outside departments and vendors.
• Identifies issues and escalates those issues to the department senior leadership or management as appropriate.
• Provides support to the department leadership with the implementation of new systems and continuous improvement efforts.
• Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements.
• Participates in required annual hazardous waste training.
• Handles hazardous waste, including container and tank management and inspections, generation of hazardous waste, and transfer of hazardous waste.
• Responds to spills per the Chemical Spill Procedures.
• Performs additional duties as assigned.

Requirements

• 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: We commit to support the well-being of our patients and treat our employees and those we serve as valued partners.
• Are Proactive & Agile: We embody a culture of engagement and action, fearlessly adapting to change.
• Act Ethically: We conduct our business in an ethical, compliant, and socially aware manner.
• Constantly Improve: We enhance our products, systems, processes, and services by reducing waste and increasing efficiency.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity.

Qualifications

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

Pay

$36.00 - $37.00 per hour, depending on experience. 10% shift differential after training period.

Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. Benefits summary.

Working Conditions

• Laboratory setting with exposure to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in a high throughput lab.
• Business demands may require extended hours.