QC Chemist I

dawarconsulting; Frederick (MD); In loco; USD 39.000 - 44.000; Tempo pieno

Descrizione del lavoro

Our client in Frederick, MD is seeking a QC Chemist I to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR assays. The role includes data monitoring, record review, and CoA generation support, with GMP compliance as a core focus.

The position offers long-term contract potential with conversion to FTE, located in Frederick, MD, and compensation at $30/hour on a W2 basis, plus medical, paid sick leave, and 401K benefits.

Competenze

• Bachelor’s Degree or AA Degree or High School Degree.
• GMP, SOPs and quality control experience preferred.

Mansioni

• Test raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR.
• Collaborate with internal and external teams to maintain the lab in optimal condition.
• Monitor and trend data; review routine test data and documents for in-process testing and release.
• Provide information to support generation of CoAs for product release.
• Maintain laboratory instruments, calibrations and routine maintenance.
• Draft or revise SOPs and qualification/validation protocols and reports.
• Monitor GMP systems to ensure compliance with policies.

Conoscenze

GMP knowledge

SOPs

Quality control

Cell bioassays

Flow Cytometry

ELISA

PCR

qPCR

Formazione

Bachelor’s Degree

AA Degree

High School Diploma

Strumenti

None

Descrizione del lavoro

Our client, a world leader in life sciences and biotechnology, is looking for a “QC Chemist I” based in Frederick, MD.

Job Duration: Long Term Contract (Possibility of Conversion to FTE) Pay Rate : $30/hr on W2.

Company Benefits: Medical, Paid Sick leave, 401K.

Key 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.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.

Qualifications

• Bachelor’s Degree OR AA Degree OR High School Degree

Preferred Qualifications

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