Quality Assurance Specialist

3 weeks ago


Maryland, United States ApTask Full time
About the Role:

The Quality Control Chemist will be responsible for performing testing of raw materials, intermediates, and final products by following analytical methods such as cell-based bioassays, flow cytometry, ELISA, and qPCR assays. This role requires strong knowledge of GMP, SOPs, and quality control processes. The ideal candidate will have a strong background in analytical techniques, including flow cytometry, ELISAs, PCR, and cell bioassays, and be well-versed in various quality systems and regulatory requirements.

Key Responsibilities:

Perform testing of raw materials, intermediates, and final products by following analytical methods
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 generation of CoAs for product release
Maintain 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 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

Requirements:

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 OOS's 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
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)

About ApTask:

ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries.

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