Core Hours: Sunday - Thursday, 7:00 am - 3:30 pm- Training hours may varyPurpose and ScopePerforms 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 advanced preparation techniques and analysis methods. Expertise with introductory and intermediate techniques and analysis methods.
- Mentor and train junior analysts in a variety of sample preparations and lab techniques. Demonstrate an aptitude to train others regarding documentation practices and regulations.
- Accountable for documenting all activities and maintaining records according to good documentation practices.
- Accountable for proper use, care, maintenance and troubleshooting of instrumentation.
- Perform method transfers on a variety of analyses. Guides the department in the implementation of new technologies.
- Provide detailed accounts of testing performed to investigators, perform investigational testing as directed by a primary investigator. Perform the initial stages of a laboratory investigation with guidance from a primary investigator.
- Make scientific recommendations to management/technical writers regarding QC procedures. Able to take recommendations and incorporate those recommendations into a document to ensure the appropriate changes are made. Responsible for acting as a technical reviewer for document updates to ensure changes that are made are justified and scientifically sound.
- Become a technical expert in a variety of techniques or instrumentation.
- Completes tasks on time and with minimal errors. Follows all procedures applicable to job functions to ensure high quality of work. Mentors others in the department to ensure department maintains high standards for 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.
- Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Exhibits a positive and understanding attitude at all times. Remembers to look at situations from all aspects. Assists co-workers with the completion of tasks. Learning to identify areas of contention on a team and working with management to correct.
- Will represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary. May provide technical expertise to determine root cause of aberrant method transfer results.
- 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.
- A leader in compliance. Demonstrates leadership aptitude in technical functions.
- Identifies issues and possible solutions and escalates those issues and solutions 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.
- 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. Respond to spills per the Chemical Spill Procedures.
- Perform additional duties as assigned.
Knowledge, Skills & Abilities- Competent in the knowledge and application of government regulations for drugs or medical devices including GMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
- Experienced in the use of USP, NF and other compendia.
- Effective written and oral communication skills.
- Ability to interpret, understand and follow advanced analytical procedures and calculations.
- Experience contributing to laboratory investigations.
- Proficient with training and mentoring junior analysts.
Education& Experience- Bachelor's degree in scientific discipline, preferably in Chemistry or Biochemistry.
- 4 or more years of experience in an analytical laboratory position.
Working Conditions- 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.
Compensation and Benefits- Pay: $43.00 - $44.00 per hour, depending on experience
- Shift Differential: 10%
- 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.
