Quality Assurance Specialist

1 week ago


Frederick, Maryland, United States RICEFW Technologies Full time
Job Title: Quality Control Chemist

Location: Onsite - Shift flexibility preferred

We are seeking a highly skilled Quality Control Chemist to join our team at RICEFW Technologies.

Job Summary:

The Quality Control Chemist will be responsible for performing testing of raw materials, intermediates, and final products by following analytical methods. This includes working with internal and external resources to maintain the lab in an optimal state, monitoring and trending data, and completing routine record reviews of test data and related documents.

Responsibilities:
  • Perform testing of raw materials, intermediates, and final products by following analytical methods, including cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
  • Work with internal and external resources to maintain the lab in an optimal state, including calibration and routine maintenance of laboratory instruments.
  • Assist with monitoring and trending data, complete routine record reviews 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 specifications (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.
Requirements:
  • Bachelor's Degree OR
  • AA 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).
Preferred:
  • Experience in the biotech and/or pharmaceutical industry.


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