Quality Control Chemist I - GMP Biotech Lab

R Dpartners; Frederick (MD); On-site; USD 50,000 - 63,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Expense reimbursement

Online timecard approval

Job summary

R&D Partners in Frederick, MD is hiring a Quality Control Chemist I to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR, ensuring compliance with GMP and quality control standards. The role includes data monitoring, routine review of test records for in-process testing and release, and maintaining laboratory instruments.

Candidates should have a related degree plus experience or equivalent, and will contribute to SOPs

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
• Strong knowledge of GMP, SOPs and quality control processes.
• Identifying, writing, evaluating, and closing OOS’s and investigations.

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.

Skills

GMP knowledge

SOP knowledge

Quality control processes

Education

Bachelor's degree

AA degree

High school diploma

Job description

R&D Partners in Frederick, MD is hiring a Quality Control Chemist I to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR, ensuring compliance with GMP and quality control standards. The role includes data monitoring, routine review of test records for in-process testing and release, and maintaining laboratory instruments.

Candidates should have a related degree plus experience or equivalent, and will contribute to SOPs