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Quality Control Chemist

Job in Frederick, Frederick County, Maryland, 21709, USA
Listing for: Planet Pharma
Full Time position
Listed on 2026-10-01
Job specializations:
  • Quality Assurance - QA/QC
    Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Position: Quality Control Chemist I
Reference: 631281

Posted:

Location:

Frederick, MDCompany:
Planet Pharma Group Contact:
Applications Email: applications

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
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