Quality Control Technician
1 month ago
Summary of Position
We are seeking a highly motivated and experienced QC Technician to play a key role in the development of Toralgen’s platform delivery technology. The successful candidate will be assisting in the day-to-day analytical/assay method development and formulation characterization operations. They may also be involved in the annual equipment maintenance/calibration activities and training on the new equipment’s IQ/OQ as needed.
Key Responsibilities
· Perform HPLC/DLS preparation (i.e. cleaning, setup, assembly etc.,) per the related instrument/operation SOPs.
· Run HPLC and DLS for the formulation characterization following the detailed experiment/assay protocols in an efficient manner.
· Follow good documentation practices by recording all the analytical steps followed in the lab notebooks and analytical run protocol/records.
· Always maintain accurate, neat, error free batch records, lab notebook entries and logbooks.
· Perform routine pH meter calibration/analytical balances weight checks and record in the logbooks.
· Assists with troubleshooting equipment related issues; and make recommendations for smooth operations.
· Prepare clean glassware’s, reagents, buffers and solutions as requested to run the HPLC analysis.
· Adhere with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements.
Basic Qualifications
- Bachelor’s or Associates Degree in a relevant field (e.g., chemistry, bio-chemistry, biology, analytical chemistry, pharmaceutical sciences).
- 2-3 years of experience in an Industry laboratory setting.
- Hands-on experience in HPLC and DLS instrument operation and software is a must.
- Good knowledge of cGMPs and following ICH guidelines is highly preferred.
· Excellent organizational and project/time management skills are required.
· Ability to work within a team and as a strong team player with strong collaboration mind set, communication and interpersonal skills is a must.
Additional Skills/Preferences
· Experience with working in a networked technical organization with proven skills in collaboratively working with suppliers and alliance partners.
· Ability to effectively influence, to gain commitment within team, cross-functionally, and across levels.
· A good working knowledge of computer assisted equipment, HPLC software and Microsoft excel is highly preferred.
- Polymeric nanoparticles/protein/peptides/mAbs and small molecule analytical characterization experience will be an asset.
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