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Quality Assurance Chemist

2 months ago

Baltimore, Maryland, United States Alpha Consulting Group Inc Full time

Position Title: Quality Assurance Chemist

Location: Frederick, MD

Shift: Onsite Swing Shift - (Wed-Sat 1:00 pm - 11:30 pm)

Job Overview:

We are seeking a dedicated Quality Assurance Chemist to join our team. The successful candidate will be responsible for conducting thorough testing of raw materials, intermediates, and final products utilizing various analytical methods including cell-based bioassays, flow cytometry, ELISA, and qPCR assays.

Key Responsibilities:

  • Conduct testing and analysis of materials to ensure compliance with quality standards.
  • Collaborate with internal and external resources to maintain optimal laboratory conditions.
  • Assist in monitoring and trending data, including routine record reviews of test data and related documentation.
  • Provide necessary information to support the generation of Certificates of Analysis (CoAs) for product release.
  • Ensure laboratory instruments are properly calibrated and maintained.
  • Draft or update Standard Operating Procedures (SOPs), qualification/validation protocols, and reports.
  • Support lab investigations concerning out-of-specification (OOS) results and participate in root cause analysis.
  • Deliver updates during daily and weekly meetings to ensure team alignment.
  • Monitor compliance with Good Manufacturing Practices (GMP) and related policies.
  • Review proposed changes to systems, procedures, and methods, as well as submissions to regulatory agencies.
  • Collect metric data to drive continuous improvement initiatives.
  • Perform additional duties as required.

Basic Qualifications:

  • Bachelor's Degree in a relevant field, or
  • Associate's Degree with 2+ years of experience in biotechnology or a related field with Quality Control experience, or
  • High School Diploma with 3+ years of experience in biotechnology or a related field with Quality Control experience.

Preferred Qualifications:

  • In-depth knowledge of GMP, SOPs, and quality control processes.
  • Experience in identifying, documenting, and resolving OOS results and investigations.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant applications.
  • Strong written and verbal communication skills.
  • Ability to work independently and communicate effectively with scientific and technical personnel.
  • Familiarity with various analytical techniques relevant to biopharmaceutical testing.
  • Understanding of quality systems and regulatory requirements (21 CFR Part 11/210/211).
  • Experience in the biotechnology and/or pharmaceutical industry is preferred.

Thank you for considering this opportunity with Alpha Consulting Group Inc.