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Quality Control Analyst

2 months ago

Frederick, Maryland, United States Intelliswift Software Full time

Job Title: Quality Control Technician

Company: Intelliswift Software

Location: Onsite

Duration: Contract Position

Key Responsibilities:


• Conduct thorough testing of raw materials, intermediates, and final products utilizing established analytical techniques such as cell-based bioassays, flow cytometry, ELISA, and qPCR assays.


• Collaborate with both internal teams and external partners to ensure the laboratory is maintained in optimal working condition.


• Assist in monitoring and trending data, and perform routine reviews of test data and associated documentation for in-process testing, drug substance, and drug product release. Provide necessary information to support the generation of Certificates of Analysis (CoAs) for product release.


• Ensure laboratory instruments are properly calibrated and maintained.


• Author or update Standard Operating Procedures (SOPs), qualification/validation protocols, and reports.


• Support laboratory investigations related to out-of-specification (OOS) results and participate in identifying root causes for deviations in analytical procedures.


• Provide regular updates during daily and weekly meetings.


• Oversee the current Good Manufacturing Practice (GMP) systems to ensure adherence to documented policies.


• Review proposed modifications to systems, procedures, methods, and submissions to regulatory bodies as necessary.


• Collect metric data to facilitate continuous improvement in assigned areas.


• Undertake additional responsibilities 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, along with Quality Control experience OR


• High School Diploma with 3+ years of experience in biotechnology or a related field, including Quality Control experience.

Preferred Qualifications:


• Comprehensive understanding of GMP, SOPs, and quality control processes.


• Experience in identifying, documenting, evaluating, and resolving OOS occurrences and investigations.


• Proficient in Microsoft Word, Excel, PowerPoint, and other relevant applications.


• Excellent written and verbal communication skills.


• Ability to work independently and effectively communicate with scientific and technical personnel.


• Familiarity with various analytical techniques, including flow cytometry, ELISAs, PCR, and cell bioassays, as well as other relevant methods for biopharmaceutical testing.


• Knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).


• Preferred: Experience within the biotechnology and/or pharmaceutical sectors.