We are seeking a detail-oriented and experienced Quality Control Chemist to join our team in Frederick, MD. This role is critical in supporting the testing of raw materials, intermediates, and final products, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements. The ideal candidate will have experience in analytical methods including cell-based bioassays, flow cytometry, ELISA, and qPCR assays. This is an onsite role with shift flexibility preferred.
Key Responsibilities:
- Conduct testing on raw materials, intermediates, and final products using various analytical methods such as cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
- Work with internal and external teams to maintain optimal lab conditions.
- Monitor and trend data, review test data and related documents, and support the generation of Certificates of Analysis (CoAs) for product release.
- Perform routine calibration and maintenance of laboratory instruments.
- Author and revise Standard Operating Procedures (SOPs), qualification/validation protocols, and reports.
- Assist in lab investigations related to out-of-specifications (OOS) results and participate in root cause analysis for deviations.
- Provide updates during daily and weekly team meetings.
- Monitor GMP systems to ensure compliance with policies and regulations.
- Review proposed changes to systems, procedures, methods, and regulatory submissions.
- Gather metrics for continuous improvement in areas of responsibility.
- Perform other duties as assigned.
Basic Qualifications:
- Bachelor’s Degree in a related field OR
- Associate’s Degree and 2+ years of experience in biotechnology or a related field, with Quality Control experience OR
- High School Degree and 3+ years of experience in biotechnology or a related field, with Quality Control experience
Preferred Qualifications:
- Strong knowledge of GMP, SOPs, and quality control processes.
- Experience with identifying, writing, evaluating, and closing OOS results and conducting investigations.
- Proficient in MS Word, Excel, PowerPoint, and other relevant applications.
- Excellent written and verbal communication skills.
- Ability to work independently and effectively collaborate with scientific and technical personnel.
- Expertise in analytical techniques such as flow cytometry, ELISA, PCR, and cell bioassays.
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
- Experience in the biotech or pharmaceutical industry is highly preferred.