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Requisition Title: Quality Control Chemist - I*
Description: Job Title - Quality Control Chemist
Location - Frederick, MD
Onsite Swing Shift - (Wed-Sat 1:00 pm -23:30 pm shift)
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.
Full Time
$60k-76k (estimate)
06/15/2024
07/02/2024
eteaminc.com
SOUTH PLAINFIELD, NJ
500 - 1,000
1999
Private
BIPIN TAHKUR
$50M - $200M
IT Outsourcing & Consulting
eTeam provides industry-specific, SOW-based services, and global contingent workforce managementsolutions.
The following is the career advancement route for Quality Control Chemist positions, which can be used as a reference in future career path planning. As a Quality Control Chemist, it can be promoted into senior positions as a Biologist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Control Chemist. You can explore the career advancement for a Quality Control Chemist below and select your interested title to get hiring information.