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Quality Control Scientist

2 months ago

Frederick, United States Intelliswift Software Full time

Job Title - Quality Control Chemist

Location - Frederick, MD


Responsibilities (include but are not limited to):

• Test raw materials, intermediates, and final products using the following analytical methods: 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 the generation of CoAs for product release.

• Maintains 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 the 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.

• Perform other duties as required.



Basic Qualifications:

• 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 OOSs 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 CRF Part 11/210/211).

• Preferred: Experience in the biotech and/or pharmaceutical industry.