Quality Control Analyst I

Job Description

Duties and Responsibilities:

• Perform routine and non-routine chemical testing of commercial, validation and stability samples in accordance to written methodology.
• Perform qualitative and quantitative analyses using analytical instrumentation such as HPLC; GC, UV/Vis, KF and FTIR.
• Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data.
• Analyze data aProductst approved specifications, notifying management of any OOS and aberrant results.
• Actively participate in root cause problem solving during laboratory investigations, provide input for effective corrective and preventive actions.
• Perform routine maintenance on lab equipment, as needed.
• Perform peer review of laboratory testing, as required.
• Basic knowledge and understanding of USP, cGMP, and FDA regulations.
• Create and maintain lab record documentation (notebooks and computer based) according to GMPs and GLPs.
• Demonstrate the philosophy of Right First Time.
• Maintain a clean and safe work environment and follow safety procedures and policies.
• Provide feedback on systems and processes to promote continuous improvement and champion selected changes.
• Grow in the job, accountable for establishing and accomplishing annual personal development goals.
• Contribute to department and site goals.
• Communicate clearly and well within a team environment.
• Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives.
• Shares information with others – keeping management informed and helping department to meet the goals.
• Actively participate in regular one-on-one meetings with direct manager.
• Communicate external to the department, where applicable.
• Collaborate effectively to achieve team and organizational goals.
• Prioritize assigned work to maximize time and equipment efficiency.
• Work independently with limited supervision for routine assignments.
• Troubleshoot problems encountered with methods and instruments – routinely solve, choosing among clearly defined alternatives.
• Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.

Must Have:

• BS or higher in science related discipline, chemistry is preferred.
• Lab experience.
• Recent College graduates are welcomed.
• Experience with compendial testing.
• Wet chemistry techniques.