QC Chemist

Job Title: Quality Control Chemist

Location: Frederick, MD

Onsite

W2 Only (NO C2C)

Job Duration: 12 months

Job Description : 

·        Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.

·        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. 　

·        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.

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 industry.