QC Analyst II
$65,000–$104,650 year
On-site · Titusville, New Jersey, United States
Job Summary
Perform analytical testing in GMP-compliant QC lab environments, maintain and validate analytical methods, and support qualification/validation activities. Utilize electronic systems (LIMS, MES, Empower) for execution and documentation of testing, complete method qualification/validation/transfer with mentorship, perform instrument calibration/maintenance, assist internal audits, and contribute to CAPAs and investigations. Collaborate with global project teams and participate in continual improvement within the QC function, while adhering to regulatory requirements and maintaining training compliance.
Required Qualifications
- Bachelor's degree and/or equivalent degree required; preferably in Science or related field.
- At least 2 years of experience in a GMP-regulated, science-related field.
- Detailed knowledge of analytical technologies used in the QC laboratory.
- Skilled in performing intermediate and some advanced testing within the functional laboratory, using HPLC and/or UPLC.
- Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory.
- Basic knowledge of compendial (USP, EP, JP, etc.) requirements
- Basic technical writing skills.
- Ability to manage an individual project with mentorship from supervision/management.
- Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
- Ability to makes GMP laboratory decisions both independently and with occasional mentorship from QC supervisor.
- Performs independent troubleshooting and has basic root cause analysis skills.
- Works directly with supervision for resolution of complex issues.
- Experience with Karl Fischer analysis preferred.
- Experience with Dissolution apparatus and UV preferred.
- Experience authoring Standard Operating Procedures preferred.
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