Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
The Senior CQ Analyst, Performs basic analysis for raw materials, in process, finished products, and/or TSR/validation/investigational testing in a safe, compliant, and efficient manner. The Job responsibilities include performing wet chemistry and analytical testing to evaluate the quality of the incoming raw materials and analyze the finished product to demonstrate that the quality of our products meet the high standards of quality.
Report testing results through computerized systems, or through standard laboratory paper-based documentation. Other related duties essential to these operations or special assignments as required.
Provides technical support as necessary to the assigned laboratory. Investigates, analyzes, problem solves, and communicates technical information to internal and external customers. Other related duties essential to these operations or special assignments as required.
Trains and supports inexperienced analysts, working as a Certified Fellow Employee and mentor to aid in their development as analysts.
Also, should perform a variety of job functions in the quality control laboratory which including development of training material, review and development of laboratory documents including SOP's, evaluation & installation of new lab equipment, and new testing methodologies. Other related duties essential to these operations or special assignments as required.
Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
Follows procedures at all times, adopting cGMP, cGDP practices.
Follows supervisor directions at all times.
Able to function independently, but asks questions as necessary
Accepts dynamic work sequences
Must be self-motivated and work with minimal direction
Must have strong technical and/or leadership skills
Must be viewed by peers, supervisors, and managers as having strong technical and/or leadership skills
Routinely participates in daily Shift Handover and/or CQ Performance huddles, including discussions on improving planning communication, and teamwork efforts in the CQ laboratory (where applicable for function).
Actively participates in daily and weekly planning discussions with his/her teammates and supervision (as needed) offering suggestions to improve Right First Time and schedule adherence as needed
Works with supervision and management to identify opportunities to improve testing efficiencies and actively participates in subsequent related projects
Consistently communicates work sequence status to supervisor in a timely manner.
Where scheduled work was not achieved, actively participates in discussions to identify opportunities for correction and improvement and actively works on efforts to recover adherence gaps
Demonstrates engagement in helping to achieve CQ laboratory, team, and individual goals.
When faced with roadblocks and issues, routinely offers suggestions for improvements and actively participates in associated improvement activities wherever possible
Is a positive influence on the CQ laboratory, often going out of his/her way to support and assist teammates on the same shift and across shifts wherever possible.
Maintains an on-time training
Must have strong organizational skills and ability to multi-task…