Quality Control Chemist

ACL Digital; Frederick (MD); On-site; USD 55,000 - 75,000; Full time

Job summary

ACL Digital is hiring for a Quality Control Analyst to perform testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. The analyst will maintain the lab, review data for CoAs, and support product release in a GMP environment.

The role requires an AA degree with 2+ years in biotech or a related field, or a high school diploma with 3+ years in biotech/QC.

Qualifications

• AA Degree with 2+ years’ biotech or QC experience OR High School Degree with 3+ years’ biotech/QC experience.
• Experience with GMP, SOPs and quality control processes.
• Proficient with MS Word, Excel, PowerPoint and related applications.
• Ability to communicate and work independently with scientific/technical personnel.

Responsibilities

• Test materials and products using cell-based bioassays, flow cytometry, ELISA and qPCR.
• Maintain lab with internal/external resources to keep it in optimal state.
• Review test data and prepare information for CoAs and product release.
• Calibrate and maintain laboratory instruments.
• Draft or revise SOPs, qualification/validation protocols and reports.
• Support investigations of OOS results and determine root causes.
• Provide updates at daily/weekly meetings and monitor GMP systems for compliance.
• Review proposed changes to systems and procedures for regulatory submissions.
• Gather metrics for continuous improvement.
• Perform additional duties as required.

Skills

GMP knowledge

Quality control

Investigations

Documentation

Statistical thinking

Communication

Education

AA degree in biotechnology or related field

High School Diploma with 3+ years of biotech/QC experience

Tools

MS Word

MS Excel

PowerPoint

Job description

Responsibilities (include but are not limited to):

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.


• Work with internal and external resources to maintain 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.


• Maintains laboratory instruments for calibration and routine maintenance


• Author or revise SOPs, qualification/validation protocols and reports.


• Asist 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.


• Perform other duties as required.

Basic Qualifications:

• 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, Power Point and other applications.


• 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.