Immediate need for a talented Quality Control Analyst (QC Analyst) . This is a 12+ Months Contract opportunity with long-term potential and is located in Fredrick, MD (Hybrid) . Please review the job description below and contact me ASAP if you are interested.
Job ID:
Pay Range: $28 - $30/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)
Key Responsibilities:
- Perform QC analytical testing of raw materials, intermediates, drug substances, and final drug products according to approved analytical methods and SOPs.
- Perform laboratory assays including Flow Cytometry, ELISA, qPCR/PCR, cell-based bioassays, and other applicable biopharmaceutical analytical methods.
- Review and trend laboratory data and complete routine review of test results and supporting documentation.
- Support in-process testing and drug substance/drug product release activities.
- Provide testing information and analytical data to support Certificate of Analysis (CoA) generation.
- Maintain laboratory instruments and equipment, including calibration, routine maintenance, and troubleshooting activities.
- Work with internal and external resources to maintain the laboratory in an optimal, compliant, and inspection-ready condition.
- Author, revise, and maintain SOPs, qualification/validation protocols, reports, and other controlled documents.
- Support laboratory investigations associated with Out-of-Specification (OOS) results.
- Participate in deviation investigations and assist with root-cause analysis related to analytical procedures.
- Ensure accurate and timely documentation of laboratory activities in accordance with GMP and data integrity requirements.
- Monitor applicable GMP quality systems and ensure compliance with established procedures and policies.
- Support review of proposed changes to laboratory systems, procedures, analytical methods, and related regulatory documentation.
- Gather and analyze laboratory metrics to support continuous improvement.
- Communicate testing status, laboratory activities, issues, and priorities during daily and weekly meetings.
- Collaborate effectively with Quality, Manufacturing, Analytical, Scientific, and Technical teams.
- Perform other QC laboratory duties as assigned.
Key Requirements and Technology Experience:
- Bachelor's degree in Biology, Biochemistry, Chemistry, Biotechnology, Microbiology, or a related scientific field; OR
- Associate's degree + 2 years of experience in biotechnology or a related field with Quality Control experience; OR
- High School Diploma/GED + 3 years of experience in biotechnology or a related field with Quality Control experience.
- Experience working in a biotechnology, biopharmaceutical, pharmaceutical, or biologics laboratory.
- Hands-on experience in a GMP Quality Control environment.
- Strong understanding of GMP, SOPs, laboratory quality systems, and QC processes.
- Experience with OOS investigations, deviations, root-cause analysis, and investigation documentation.
- Hands-on experience with one or more of the following:
- Flow Cytometry / FACS
- ELISA
- qPCR / PCR
- Cell-based assays
- Bioassays
- Other analytical methods used for biopharmaceutical testing
- Working knowledge of 21 CFR Part 11, 21 CFR Part 210, and 21 CFR Part 211.
- Experience with laboratory instrument calibration, maintenance, and troubleshooting.
- Experience writing or revising SOPs, protocols, validation/qualification documents, and technical reports.
- Strong understanding of laboratory documentation and data integrity requirements.
- Proficiency with Microsoft Word, Excel, PowerPoint, and other standard laboratory applications.
- Strong written and verbal communication skills.
- Ability to work independently while collaborating effectively with scientific and technical personnel.
- Strong attention to detail and ability to work effectively in a fast-paced, regulated environment.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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