Quality Control Chemist
Job Title - Quality Control Chemist
Location - Frederick, Maryland
Onsite Front end Day Sun-Wed 7am-5pm
Job Duration: 3+ months
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.
-
Seniority level
Associate -
Employment type
Contract -
Job function
Health Care Provider, Manufacturing, and Research -
Industries
Chemical Raw Materials Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Cube Hub Inc. by 2x
See who you knowGet notified about new Quality Control Chemist jobs in Frederick, MD.
Sign in to create job alertSimilar jobs
People also viewed
-
Analytical Chemist
Analytical Chemist
-
Scientist II
Scientist II
-
Analytical chemist
Analytical chemist
-
Formulation Chemist
Formulation Chemist
-
Analytical Chemist
Analytical Chemist
-
Quality Control Chemist
Quality Control Chemist
-
R&D Chemist - 145578
R&D Chemist - 145578
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub