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QC Analyst II - 2nd Shift (Monday - Friday)
at TOLMAR Inc.
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. Employee will be trained 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.
- Employee is responsible for ensuring that company and regulatory data integrity guidelines are consistently followed.
- Participates in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings. Hazardous waste involvement may include but is not limited to making waste determinations, generation, transportation, satellite accumulation, storage and disposal of multiple types of waste streams, and container management and inspections. Respond to spills per company procedure. Maintain compliance to all Tolmar health and safety policies, as well as OSHA standards.
- Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Willing to assist co-workers in the completion of tasks.
- Will represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary.
- Interacts respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning. Appropriately resolves differences of opinion.
- Upon delegation, may be responsible for representing 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.
- Provide 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.
- 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.
- The QC Analyst II is expected to operate within the framework of Tolmar’s Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
- Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
- Two or more years of experience in an analytical laboratory position.
- Laboratory setting. Will be exposed 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 order to meet important timelines in a high throughput lab.
- Business demands may present a need to work extended hours.
- Core hours for this position are from 2:00 pm - 11:00 pm, Monday - Friday