Quality Control Analyst

2 weeks ago


Frederick, Maryland, United States ACL Digital Full time

Job Title - Quality Control Chemist

Duration: 6+ months contract

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.



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