Position Summary - The QC Chemist II position performs testing using a variety of analytical techniques. The successful candidate ensures that Testing and Documentation is compliant with GMP regulations and internal procedures. The position will be operating within a GMP environment for an Analytical QC team in a CDMO.
Essential Functions
- Well versed with various laboratory techniques, including, but not limited to HPLC, GC, titrations, and various wet chemistry techniques.
- Carry out routine laboratory work as directed by management and/or senior laboratory personnel with minimal supervision
- Performs complex analyses with moderate supervision.
- Conduct routine analytical experiments using established analytical methods and procedures.
- Data entry into reports, as directed by senior laboratory personnel.
- Verify simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance.
- Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting.
- Review and maintain laboratory notebooks.
- Ensure data collected is processed and submitted for review in a timely manner.
- Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination and report writing.
- Maintains laboratory inventory of chemicals, standards, and consumables and orders materials as necessary.
- Revises existing methods, SOPs, and Work Instructions as needed.
Supervisory responsibilities:
- Direct Reports: None
- Indirect Reports: None
Key Relationships:
- Manufacturing Operations
- Analytical R&D
- Quality Assurance
Travel requirements:
Education and Experience
- B.S with 4-6 years experience, or M.S with 3-4 years of experience: focus in chemistry, pharmaceutics or related scientific discipline
- 2-5 years´ experience in a GMP laboratory setting in the pharmaceutical industry
- Must have experience with general laboratory instruments, such as FTIR, Particle Size, Titration Equipment, and UV-Vis
- Must have experience in HPLC testing and troubleshooting
- Must have prior experience with raw materials or finished products testing in a GMP pharmaceutical environment.
- Must be well versed with Good Documentation Practices and ALCOA++ principles.
- Technical report writing proficiency preferred
Knowledge, Skills, and Abilities
- Proficiency in Empower, MS Excel, and MS Word
- Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
- Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical and has a right first-time mentality
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.
- Requires constant standing, walking, seeing, gripping, & hearing
- Requires frequent sitting, bending, pushing, & reaching
- Requires occasional carrying under 20 LBS.
- Requires frequent lifting & pulling under 20 LBS, occasionally 20 - 60 LBS.
- Requires occasional twisting
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.