Quality Assurance Specialist

4 weeks ago

Los Angeles, California, United States Grifols Shared Services North America, Inc Full time

We are seeking a highly skilled Quality Assurance Specialist to join our team at Grifols Shared Services North America, Inc. The successful candidate will be responsible for performing routine and non-routine chemical and biochemical assays on protein-based therapeutics and raw materials.

Key Responsibilities:

  • Perform various QC / Quality Control testing (i.e. product release testing, stability testing, in-process testing, and other protocol testing) as directed by the laboratory supervisor or senior chemist.
  • Compile and enter data into computer database (i.e. LIMS - Laboratory Information Management System) to be used for reporting and trending purposes.
  • Review test results against specifications.
  • Share general responsibilities for laboratory equipment maintenance and calibration, housekeeping, and other lab support functions (e.g., inventory of consumables and reagents).
  • Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
  • Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
  • Strict adherence to procedures and practices according to FDA regulations.
  • Strong emphasis on documentation according to FDA regulations.
  • Adhere to departmental corporate safety policies.

Requirements:

  • Bachelor's degree in Chemistry, Biochemistry, Biology or closely related scientific discipline is required.
  • Related experience in a pharmaceutical, GMP, or FDA regulated testing laboratory is preferred.
  • Requires a basic understanding of analytical methodologies and protein biochemistry (e.g. IC, HPLC, GC, etc.).
  • Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
  • Must be proactive, results oriented, and have strong attention to detail.
  • Self-starter with strong work ethic and the ability to exercise good judgment.
  • Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
  • Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
  • Excellent verbal and written communication skills in the English language.
  • Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • Specific experience with LIMS (Laboratory Information Management System) is preferred.
  • Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.

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