Quality Control Associate
1 month ago
Pay range of $24.00 - $25.00 per hour
Ideal Candidate: Must have GMP Chemistry or biology experience specifically HPLC/UHPLC (high and ultra-high liquid chromatography). Bachelors and 2 years GMP experience preferred. Must have software knowledge in Teams, Excel, and Word. Nice to have computer skills, Share point, smart sheets or LIMS.
Job Details: The Associate Quality Control will support the QC analytical biochemistry team by performing testing HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CE (capillary electrophoresis), CEX (cation exchange), HILIC (hydrophilic interaction). This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.
Under general supervision, this position is responsible for performing analytical testing and support in the HPLC/Capillary Electrophoresis (CE) group in Clinical Quality Control.
Responsibilities include:
Responsible for one or more of the following activities in QC: analytical testing, sample and data management and equipment maintenance.
Perform routine laboratory procedures such as sample analysis, standard and solution preparation.
Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data.
Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.
Support introduction of new methods/techniques into the lab.
Perform basic assay and instrument troubleshooting.
May identify, recommend and implement improvements related to routine job functions.
Must learn and comply with safety guideline and basic cGMPs
Must be flexible in working schedule as required
Must be able to be on-call for CEMS as required
Preferred Qualifications
Experience in HPLC and/or Capillary Electrophoresis techniques
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to organize work, handle multiple priorities and meet deadlines
Strong written and oral communication skills
Must be detail orientated
Must be flexible and adaptable to changing priorities and requirements
Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
Demonstrate understanding of when and how to appropriately escalate
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