Analytical Chemist (Pharmaceutical)
Company: ASCENDING
Location: Chantilly
Posted on: May 28, 2023
Job Description:
JOB SUMMARYThe role of QC Biochemist/Chemist II is responsible
for supporting the operations and manufacturing process by
performing routine and non-routine analytical testing raw
materials, in-process, finished formulations, stability samples,
method development and/or transfers, and cleaning validations.
Follows standard procedures to complete tasks, some of which may
vary in scope, sequence, complexity, and timing. Responsible for
the safe and efficient execution of job duties.Key
Accountabilities:
- Conduct routine analytical/microbiological testing of raw
materials, packaging materials, finished product release and
stability using approved methods and various instrumentation while
adhering to cGMP and established policies.
- Conduct analytical USP method verifications, validations, and
method transfer activities for raw materials and finished dosage
forms.
- Perform the Calibration, Qualification, Preventive maintenance
and routine trouble shooting of analytical instruments like UPLC,
HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto
titrator, FT-IRS spectrophotometer, Polarimeter and
Refractometer.
- Compile laboratory test data and perform appropriate analyses
that include physical (solubility, viscosity),chemical (titration)
and analytical (FTIR, HPLC, ICP-MS, UV-Vis, KF, IC) testing
etc.
- Complete documentation needed to support testing procedures
including test forms and logbooks. ---Interpret test results,
compare them to established specifications and control limits, and
ensure appropriateness of data for release. Treats data with a high
level of integrity and ethics.
- Participate in out-of-specification and failure investigations.
Support all aspects of laboratory investigations.
- Prepare, review and approve analytical data, technical reports
and analytical methods.
- Coordinate Microbiological, preservative efficacy/
antimicrobial effectiveness testing requirement as per USP/USP-NF
for Active pharmaceutical ingredients, Inactive and Finished
products and stability samples for regulatory filings.
- Understands and runs processes to meet the assigned schedule
and standards/routers; when this is not achieved, participates in
the debrief to understand the reasons why and what needs to be
corrected moving forward.Preferred Knowledge & Skills:
- Strong knowledge of the major analytical techniques: HPLC/UPLC,
GC, dissolution, etc. FT-IR, FDA/ICH regulations.
- Experie ce -
- Solid knowledge of FDA/ICH regulations.Required Experience &
Education:
- BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or
Bio-technology or related field.
- At least 5 years -of experience in using analytical instrument
techniques (HPLC/GC/FT-IR, UV-Vis, Dissolution Apparatus,
-Ovens/Auto Titrators/KF Titrator/Particle size analyzers/
Ion-Chromatography).Powered by JazzHR
Keywords: ASCENDING, Chantilly , Analytical Chemist (Pharmaceutical), Healthcare , Chantilly, Virginia
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