Manufacturing Quality Assurance Engineer II

2 weeks ago

Fremont, California, United States Integrated Resources Full time

Job Overview:
Position: Manufacturing Quality Assurance Engineer II, Stability

Location:
Fremont, CA

POSITION SUMMARY

The Manufacturing Quality Assurance Engineer II will utilize established operating procedures (SOP) and adhere to good manufacturing practices (GMP) to conduct Surveillance testing of raw materials, filled bottle components, and finished goods kits. This role encompasses all facets of laboratory testing, including sample receipt, data generation, product verification, data analysis, instrument operation, and various other quality control laboratory support activities.


Key Responsibilities:

  • Execute analytical and functional assessments of finished product kits and/or filled bottle reagents/calibrators in accordance with approved SOPs as part of quality control surveillance testing.
  • Conduct testing utilizing chemistry clinical analyzers and accurately document results using Excel spreadsheets and workbooks.
  • Adhere to established timelines for testing and ensure compliance with standard procedures.
  • Initiate investigations for any out-of-specification results as necessary.
  • Implement stability testing protocols for newly launched products as well as those currently on the market.
  • Accurately document test outcomes, complete batch records, and record any issues or relevant information in compliance with cGMP standards.
  • Make minor revisions and updates to quality control SOPs and/or worksheets as required, and initiate procedure change orders.
  • Assist in the execution, review, and/or generation of validations for quality control processes and laboratory equipment.
  • Support stability testing of products that have incorporated new raw materials and documentation.
  • Contribute to brainstorming sessions, offering insights for problem-solving and data analysis related to quality control failures.
  • Analyze and summarize test data, maintain lot histories, and evaluate data for trends and discrepancies.
  • Perform additional responsibilities to meet departmental needs as assigned by the Supervisor.
  • Engage in PPI, Lean, and 5S initiatives as required.

Minimum Qualifications:

  • Bachelor’s degree in Chemistry, Biochemistry, or Bioscience with 1-3 years of experience in Quality Assurance/Quality Control, preferably within the medical diagnostics sector.
  • Consideration may be given for demonstrated ability and/or additional experience in lieu of a degree.
  • Familiarity with cGMP regulations and their application in the workplace is preferred.
  • Strong ability to follow written and verbal instructions with a high degree of accuracy.
  • Proficient in producing clear and comprehensible documentation.
  • Excellent verbal communication and reading comprehension skills.
  • Manual dexterity; ability to lift/move up to 20 pounds.
  • Intermediate skills in word processing and spreadsheet software.
  • Capability to manage multiple tasks concurrently.
  • Ability to work independently and perform basic data analysis to summarize results.
  • Fundamental math skills, including concentration calculations and dilutions, along with a solid understanding of algebraic concepts.

The above statements are intended to outline the general nature and level of work performed by individuals in this role. They are not an exhaustive list of all duties and responsibilities associated with this position.

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