QC Scientist II
3401 Masons Mill Rd Bryn Athyn, PA 19009 US
Job Description
Summary
The Scientist is responsible for performing testing of raw materials, in-process and finished materials, performing stability studies, following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between functions. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Perform physical and chemical analysis of raw materials, in-process, and finished materials, including stability studies, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with GMP procedures and SOPs to avoid out-of-specification situation. Assure compliance with state and federal regulations.
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzers. Creates and maintains laboratory record documentation, documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
• Use of spectrophotometer, HPLC, TOC, plate readers, osmometer, ph meter, analytical balances and titrator, experience in flow cytometry. Perform daily, monthly calibrations/ verifications on QC instruments. Other duties as assigned.
• Creates/ revises QC documents in document management system.
• Writes the non-conformances, change controls related to QC, in Trackwise.
• Participates in developing and implementing validation processes in collaboration with QA.
Education Requirements • A Bachelors’ Degree (BA/BS) in Chemistry or related science discipline is required.
• A Master Degree (MBA) in Chemistry or related science discipline is preferred.
• Depending on the position 1- 5 years of testing of chemicals/pharmaceuticals products
• Specialized knowledge in the following: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, chromatographic techniques and measuring physical parameters such as particle size.
• Must understand and apply GMP requirements applicable to quality control laboratory.
• Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to supervisor in a timely manner.
Salary Range: $70-75k. Salary will be commensurate with experience
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