QC Chemist II

MedPharm•Durham, NC

11d•Onsite

About The Position

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.

Requirements

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.
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

Nice To Haves

Technical report writing proficiency preferred

Responsibilities

Performs testing using a variety of analytical techniques.
Ensures that Testing and Documentation is compliant with GMP regulations and internal procedures.
Carries out routine laboratory work as directed by management and/or senior laboratory personnel with minimal supervision.
Performs complex analyses with moderate supervision.
Conducts routine analytical experiments using established analytical methods and procedures.
Data entry into reports, as directed by senior laboratory personnel.
Verifies simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance.
Supports testing for investigations for OOS, OOT, and aberrant results and troubleshooting.
Reviews and maintains laboratory notebooks.
Ensures data collected is processed and submitted for review in a timely manner.
Aids 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.