Quality Control Analyst III - Direct Hire Position
70-76K per year
Performs 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.
- 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 Company health and safety policies, as well as OSHA standards.
- 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 improve processes; improve processes; willingly supports new ideas and process enhancements.
- 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.
With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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