Over de functie
We are seeking an experienced QC Chemist to be part of our Quality team. The position is responsible for the following:
- Review of paperwork for compliance and sampling of raw materials
- Detailed analysis on diverse materials, issuing reports and communicating results
- Perform analytical chemistry work including but not limited to:
- Color/wet chemistry
- Karl Fisher
- Loss on drying/residue on ignition
- General lab duties as pertaining to safety and cleanliness
- Project work that may be on-going or have a specified time frame
- Perform advanced chemical analysis and investigations for high risk or out of specification products, including Corrective and Preventative Actions and follow-ups
- Perform install/operational/performance qualifications and validations
- Maintain samples and order as needed reagents, lab supplies and reference materials
- Review Quality documentation for completeness and compliance, forward as required
- Perform audits in production and warehouse to ensure continued compliance and improve processes
- Participate in continuous improvement of the Quality department and site as a whole; record keeping, lab processes, site safety, etc.
- Work environment: This job operates in a professional office environment and business casual attire with closed toe shoes is required. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This role requires Good Hygiene and facial hair must be kept well-trimmed to prevent incidental contamination during testing. Working with Biohazardous materials is also prominent.
- Physical demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this position, the employee is regularly required to sit and use hands to finger, handle, or feel objects, tools or controls or to document testing. The employee is also occasionally required to stand for long periods of time collecting or processing samples.. Specific vision abilities required by this position include close vision, color vision, and the ability to adjust focus.
- Position type/expected hours of work: This is a full-time position. Days and hours of work are typically Monday through Friday 8 a.m. to 5 p.m. but earlier or later times or weekend work may be required when the production needs exist.
Preferred education and experience
- Two (2) to Four (4) years of experience in a pharmaceutical chemistry laboratory*
- Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements* *
- Experience performing HPLC/UPLC testing using industry best practices* *
- Excellent interpersonal communication and organizational skills* *
- Qualified to work with controlled substances* *
- Knowledge and experience performing serial dilutions* *
- Experience Handling Biohazardous materials*
Maak het verschil
You possess the following qualifications, background and abilities:
- Bachelor’s degree or equivalent for QC Analytical Chemist
- Working knowledge of Current Good Manufacturing Practices and appropriate sections of CFR 210 and 211
- Ability to establish priorities, work independently and proceed with objectives without supervision
- Ability to manage project work while managing daily duties and completing all on time
- Ability to adapt to new or updated processes
- Ability to work with a variety of lab equipment such as would be used for above listed responsibilities
- Ability troubleshoot problems with analytical equipment and perform or suggest appropriate actions
- Ability to work with team members and other departments to accomplish goals
- Ability to lift 50 lbs.
- Basic typing, computer and office skills
Wat bieden wij?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.