What are the responsibilities and job description for the Quality Control Analyst position at Infotree Global Solutions?
Position Summary: The Quality Control Analyst is responsible for performing analytical testing of raw materials, drug products, and maintaining laboratory instruments in a CGMP-compliant environment.
Key Responsibilities:
- Conduct testing on raw materials, finished products, APIs, and control substances.
- Perform microbiological testing on environmental samples, purified water, and microbial limit tests (USP standards).
- Maintain and calibrate laboratory equipment, ensuring compliance with company policies, SOPs, and regulatory standards.
- Peer review laboratory test results and troubleshoot analytical methods and instruments.
- Participate in wet chemistry testing, including LOD, pH, and titration.
- Collaborate with teams to meet production, validation, stability, and project timelines.
- Ensure adherence to cGMP, DEA, and other regulatory requirements.
- Maintain safety compliance and ensure 100% completion of all required training.
Required Qualifications:
- Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry, or a related field.
- Minimum of two years of experience in a CGMP pharmaceutical, biotechnology, or environmental laboratory, with relevant experience in quality control.
- Proficiency in Labware LIMS V7, MS Office Suite, and Learning Management Systems (LMS).
- Experience with microbiology testing, including environmental samples and microbial limit tests.
- Strong knowledge of cGMP, regulatory guidelines, and quality systems.
- Excellent written and verbal communication skills for conveying technical and scientific information.
- Strong organizational and prioritization skills; self-directed and proactive.
Preferred Qualifications:
- Hands-on experience with HPLC, GC, FTIR, UV-Vis, and other analytical techniques.
- Experience with ERP systems (SAP or Oracle) and quality systems like Trackwise or Qdocs.
- Familiarity with Empower software is preferred.
Skills and Abilities:
- Solid understanding of analytical chemistry principles.
- Commitment to maintaining confidentiality, integrity, and discretion in all aspects of the role.
Salary : $30 - $33
