Quality Control Analyst I
Job Description
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 against 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.
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.
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.