Quality Control Chemist - I

Lancesoft; Frederick (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Lancesoft is seeking an onsite QC Analyst in Frederick, MD to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. You will assist with data trending, routine review of test data, and support product release documentation.

The role requires strong GMP knowledge, SOP familiarity, and the ability to communicate with scientific staff. A relevant degree with work experience and proficiency in MS Office is expected.

Qualifications

• Bachelor's Degree or AA Degree with 2+ years in biotech/Quality Control (QC).
• Or High School Diploma with 3+ years in biotech/ QC.
• Strong GMP, SOP and QC process knowledge is preferred.

Responsibilities

• Perform testing of raw materials, intermediates and final products using cell-based bioassays, Flow Cytometry, ELISA and qPCR.
• Support data trending and routine review of test data and related docs for in-process, drug substance and drug product release.
• Contribute to generation of CoAs and maintain lab instruments for calibration and maintenance.
• Author or revise SOPs, qualification/validation protocols and reports.
• Assist investigations of out-of-specification results and discuss root causes in meetings.

Skills

GMP knowledge

SOP familiarity

Quality control

Cell-based assays

Flow cytometry

ELISA

qPCR

Data trending

Documentation

Education

Bachelor's Degree

AA Degree + 2+ years experience

High School Degree + 3+ years experience

Tools

MS Word

Excel

PowerPoint

Job description

Onsite - Shift flexibility preferred (First 7 weeks of training M-F) Wednesday to Saturday Time: 7am-530pm

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 indust