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Analytical Quality Assurance Chemist

2 months ago

Frederick, Maryland, United States Collabera Full time
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Analytical Quality Assurance Chemist

Contract Type: Temporary

Location: United States

Compensation: $31.00 Per Hour

Job Overview:

As a key member of our quality assurance team, you will be responsible for ensuring the integrity and compliance of our products through rigorous testing and analysis.

Key Responsibilities:
  • Conduct comprehensive testing of raw materials, intermediates, and final products utilizing various analytical techniques including cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
  • Collaborate with both internal and external stakeholders to maintain laboratory operations at peak efficiency.
  • Assist in monitoring and trending data, and perform routine reviews of test data and associated documentation for in-process evaluations and product releases.
  • Provide necessary information to support the generation of Certificates of Analysis (CoAs) for product release.
  • Ensure laboratory instruments are properly calibrated and maintained.
  • Develop or update Standard Operating Procedures (SOPs), qualification/validation protocols, and reports.
  • Participate in laboratory investigations related to out-of-specification (OOS) results and assist in identifying root causes for deviations in analytical procedures.
  • Deliver updates during daily and weekly team meetings.
  • Oversee the current Good Manufacturing Practices (GMP) systems to ensure adherence to established policies.
  • Review proposed modifications to systems, procedures, and methods, as well as submissions to regulatory bodies, as needed.
  • Collect metric data to facilitate continuous improvement in areas of responsibility.
  • Perform additional duties as required.
Qualifications:
  • Bachelor's Degree in a relevant field OR
  • Associate's Degree with 2+ years of experience in biotechnology or a related discipline, including Quality Control experience OR
  • High School Diploma with 3+ years of experience in biotechnology or a related field, including Quality Control experience.
Preferred Skills:
  • In-depth knowledge of GMP, SOPs, and quality control methodologies.
  • Experience in identifying, documenting, and resolving OOS results and investigations.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant applications.
  • Strong written and verbal communication abilities.
  • Capable of working independently and effectively with scientific and technical teams.
  • Familiarity with various analytical techniques such as flow cytometry, ELISAs, PCR, and cell bioassays relevant to biopharmaceutical testing.
  • Understanding of quality systems and regulatory standards (21 CFR Part 11/210/211).
  • Experience in the biotechnology and/or pharmaceutical sectors is preferred.
Contact Information:
  • Recruiter: Chitrank Rastogi
Apply Now