Quality Control Chemist

The Planet Group; Frederick (MD); On-site; USD 55,000 - 85,000; Full time

Job summary

The Planet Group is seeking a Quality Control Chemist in Frederick, MD for onsite role. The candidate will perform testing on raw materials to final products using bioassays, flow cytometry, ELISA and qPCR, and will maintain lab readiness and data integrity in a regulated environment.

Ideal candidates hold a biotech QA background with strong GMP/SOP knowledge, strong communication, and ability to work independently with scientific staff; familiarity with 21 CFR Part 11/210/211 is preferred.

Qualifications

• Bachelor's or AA degree with 2+ years in biotech QA, or a high school diploma with 3+ years QA experience.
• Strong knowledge of GMP, SOPs and quality control processes.
• Experience identifying, writing, evaluating and closing OOS investigations.
• Proficient in MS Word, Excel, PowerPoint and related applications.
• Excellent written and verbal communication; ability to work independently with scientific personnel.
• Experience with analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays.
• Familiarity with 21 CFR Part 11/210/211 quality systems.
• Preferred: biotech/pharma industry experience.

Responsibilities

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR.
• Maintain lab in optimal state with internal and external resources.
• Monitor and trend data; complete routine record review for in-process testing and drug substance/product release; supply information to support CoAs.
• Maintain calibration and routine maintenance of lab instruments.
• Author or revise SOPs, qualification/validation protocols and reports.
• Assist with lab investigations regarding OOS results; determine root cause for deviations.
• Provide updates at daily and weekly meetings.
• Monitor GMP systems to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.
• Gather metrics for continuous improvement of areas of responsibility.

Skills

Quality control

GMP knowledge

SOP knowledge

OOS investigations

Strong communication

Independent work

Analytical techniques knowledge

Education

Bachelor's or AA degree in biotech

High school diploma with 3+ years QA experience

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Location: Frederick, MD Onsite - Shift flexibility preferred

.Quality Control Chemist | Requirement

• :Bachelor's Degree OR AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience O
• RHigh 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)
• .Preferred: Experience in the biotech and/or pharmaceutical industry

Quality Control Chemist | Responsibilitie

• s:Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assay
• s.Work with internal and external resources to maintain lab in an optimal stat
• e.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 releas
• e.Maintains laboratory instruments for calibration and routine maintenan
• ceAuthor or revise SOPs, qualification/validation protocols and report
• s.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 meeting
• s.Monitor the GMP systems currently in place to ensure compliance with documented policie
• s.Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriat
• e.Gather metric information for use in continuous improvement of areas of responsibilit