Quality Control Chemist - I

Job Title: Quality Control Chemist

Duration: 6 Months

Location: Frederick, MD

Onsite - Shift flexibility preferred (First 7 weeks of training M-F)

* Wednesday to Saturday

* Time: 7am-530pm

IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) 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