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Quality Assurance Specialist

2 months ago

Frederick, Maryland, United States LeadStack Inc. Full time
Job Title: Quality Control Chemist

LeadStack Inc. is a leading provider of contingent workforce solutions, partnering with top Fortune 500 brands. We're seeking a skilled Quality Control Chemist to join our team.

Job Summary:

We're looking for a detail-oriented Quality Control Chemist to perform testing of raw materials, intermediates, and final products. The ideal candidate will have a strong understanding of GMP, SOPs, and quality control processes.

Responsibilities:
  • Perform testing of raw materials, intermediates, and final products using analytical methods such as cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays.
  • Work with internal and external resources to maintain the lab in an optimal state.
  • Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance, and drug product release.
  • Supply information to support generation of CoAs for product release.
  • Maintain laboratory instruments for calibration and routine maintenance.
  • Author or revise SOPs, qualification/validation protocols, and reports.
  • Assist with lab investigations regarding out-of-specification (OOS) results.
  • Participate in determination of root cause for deviations related to analytical procedures.
  • Provide updates at daily and weekly meetings.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
Requirements:
  • Bachelor's Degree OR
  • Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR
  • High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience
Preferred Qualifications:
  • Strong knowledge of GMP, SOPs, and quality control processes.
  • Identifying, writing, evaluating, and closing OOS's and investigations.
  • Proficient in MS Word, Excel, PowerPoint, and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Well-versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).