Quality Control Chemist

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

Job summary

Lancesoft is seeking a Quality Control Chemist to join the Frederick, MD site. This onsite role offers shift flexibility with the workweek likely Wed-Sat daylight hours.

You will perform testing across raw materials, intermediates, and finished products using cell-based bioassays, flow cytometry, ELISA and qPCR, while helping to maintain a compliant, well-documented lab environment. Responsibilities include monitoring test data, generating CoAs, maintaining instruments, revising SOPs, and

Qualifications

• Bachelor's Degree or AA Degree with 2+ years in biotech/quality control.
• High School Diploma with 3+ years in biotech/quality control accepted.

Responsibilities

• Perform testing of raw materials, intermediates, and final products using methods like cell-based bioassays, flow cytometry, ELISA and qPCR.
• Maintain lab in optimum state with internal and external resources.
• Review routine test data and documents for in-process testing, drug substance and drug product release.

Skills

GMP knowledge

Quality Control

Data trending

Documentation

Strong communication

Education

Bachelor's Degree

AA Degree

High School Diploma

Tools

Flow Cytometry

ELISA

qPCR

PCR

MS Word

MS Excel

Job description

Job Title - Quality Control Chemist

Location - Frederick, MD Onsite - Shift flexibility preferred Wed-Saturday Time: Day 3PM - 1: 30AM EST

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.