Job DescriptionThe Quality Control Analyst will conduct routine and non-routine analysis and review to support in-process testing per Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements.
Effectively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalate issues to QC management.
Essential duties and responsibilities:
- Outstanding communication skills, both written and oral, and will be expected to communicate directly with management.
- Conducts analysis associated with clinical and commercial under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as International regulations.
- Performs analysis on in-process samples (developmental and commercial), raw materials, and other requested testing as per written procedures.
- Reviews data for compliance to specifications and reports and troubleshoots abnormalities.
- Ensures equipment is performing well and communicates and takes appropriate action as necessary.
- Required to follow good documentation practices.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
SHIFT: Day Shift: Monday - Friday: 8 am - 4:30 pm
Qualifications- A Bachelor's degree (B.S.) in Chemistry or a related life sciences field
- 2-5 years of relevant experience within the Industry
- Exposure to and knowledge of FDA regulations and guidelines
- Knowledge of cGMP guidelines or international regulations (i.e., International Committee on Harmonization (ICH) Q7)
- Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples. May require cross-training to support raw material and microbiological testing.
- May require handling of highly potent API material.
- Proficient with Microsoft Word and Excel
- Familiarity with the following laboratory disciplines is highly desired:
- Chemstation
-UV analysis
-HPLC
-HPLC-MS
Additional DetailsThis job has a full time weekly schedule. Applications for this job will be accepted until at least October 26, 2026 or until the job is no longer posted.
The full-time equivalent pay range for this position is $34.00 - $53.13/hr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations
Travel Required: No
Shift: Day
Duration: No End Date
Job Function: Quality/Regulatory
