Quality Control Chemist - I # 26-24651

Us Tech Solutions; Frederick (MD); On-site; USD 54,000 - 78,000; Full time

Job summary

US Tech Solutions seeks a QC Analyst for a 6‑month assignment in Frederick, MD with possible extension. The role focuses on analytical testing, data review, and CoA preparation to support product release.

You will collaborate with internal and external resources, maintain instruments, and assist in OOS investigations while ensuring GMP compliance on all documentation. Onsite with shift-based hours.

Qualifications

• Bachelor’s degree (or AA with 2+ years in biotech/quality control) required.
• High school + 3+ years in biotech/quality control acceptable.
• Strong knowledge of GMP, SOPs and quality control processes desired.

Responsibilities

• Test raw materials, intermediates, and final products using analytical methods (cell bioassays, flow cytometry, ELISA, qPCR).
• Maintain lab in optimal state with internal and external resources.
• Review test data and generate CoAs for product release; support investigations for OOS results.

Skills

GMP knowledge

Quality control processes

Root cause analysis

Documentation writing

Communication skills

Education

Bachelor’s Degree

AA Degree with 2+ years experience

High School Degree with 3+ years experience

Tools

MS Word

Excel

PowerPoint

Job description

Duration: 6 months with possible extension

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:

• 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, Power Point 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

Onsite :

Shift flexibility preferred (First 7 weeks of training M-F)

• Wednesday to Saturday
• Time: 7am-530pm

IMPORTANT:

For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

Equal Employment Opportunity (EEO):

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement:

By applying, you acknowledge that AI-assisted tools may be used during hiring.

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