Quality Control Chemist

LanceSoft Inc; Frederick (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the biotech sector seeks a Quality Control Chemist for a 6-monthcontract in Frederick, MD. This role involves performing complex testing of biopharmaceuticals and ensuring compliance with GMP and quality standards. The ideal candidate will have a strong background in biotechnology and quality control, alongside excellent communication skills. Preferred qualifications include experience in a regulated environment, familiarity with relevant analytical techniques, and the ability to work independently.

Qualifications

• Bachelor’s Degree or equivalent experience in Biotechnology.
• Strong understanding of GMP and quality control processes.
• Experience with analytical techniques like Flow Cytometry and ELISA.

Responsibilities

• Perform testing of raw materials and final products using bioassays.
• Maintain laboratory instruments and documentation.
• Assist in lab investigations for out of specifications results.

Skills

Knowledge of GMP

SOPs

Quality Control Processes

Analytical Techniques

Communication Skills

Independent Work

Education

Bachelor’s Degree

AA Degree with 2+ years experience

High School Degree with 3+ years experience

Tools

MS Word

MS Excel

Power Point

Job description

Job Title: Quality Control Chemist
Location: Frederick, MD
Shift: Sunday - Wednesday; Day or Swing Shift flexibility preferred
Contract Duration: 6 Months
Pay Range: $25.00 - $28.00 USD hourly on W2
Important: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (07:30-04:00) 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

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.