Quality Control Chemist I
Confirmed on the employer's own hiring board on Nov 6, 2026. First seen by Alion on Nov 4, 2026.
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:
* Bachelors 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 OOSs 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.
Pay ranges between 25-30/hr based on experience