Quality Control Chemist

Iconma,-Llc.; Frederick (MD); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Benefits

Referral Program

Growth opportunities

Job summary

Iconma, LLC is assisting a biopharmaceutical client in Frederick, MD to hire a Quality Control Chemist. The role performs testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR, ensuring compliance with GMP.

The ideal candidate holds a Bachelor’s or AA with related experience, can write and revise SOPs, review data, and support release of drug substances and products. On-site role with growth opportunities.

Qualifications

• Bachelor’s Degree OR AA Degree with 2+ years’ biotech/Quality Control experience OR High School Degree with 3+ years’ biotech/Quality Control experience
• Strong knowledge of GMP, SOPs and quality control processes
• Experience identifying, writing, evaluating, and closing OOS investigations

Responsibilities

• Perform testing of raw materials, intermediates and final products by analytical methods (Cell-based bioassays, Flow Cytometry, ELISA and qPCR)
• Maintain lab equipment through calibration and maintenance
• Assist with data trending, record review for in-process testing and release documentation
• Provide updates at daily/weekly meetings and support GMP compliance

Skills

GMP knowledge

SOPs knowledge

Quality control

Communication skills

Independent work

Education

Bachelor’s Degree

AA Degree

High School Diploma

Tools

MS Word

Excel

PowerPoint

Job description

Our client, a Biopharmaceutical company, is looking for a Quality Control Chemist for their Frederick, MD location.

Responsibilities

• 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.

Requirements

• 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
• 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).
• Experience in the biotech and/or pharmaceutical industry

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

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