Quality Control Chemist - I*, Maryland

Job Title: Quality Control Chemist

Location: Frederick, MD

Onsite: Shift flexibility preferred

Duration: 06 Months

Payrate: $29.85/hr on W2

Shift: Wed-Sat 07:00AM - 05:30PM

IMPORTANT:

For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (07:30-16:00) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete

Responsibilities (include but are not limited to):

" 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.

Basic 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

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.