Pfizer Senior CQ Specialist API in Rocky Mount, North Carolina
The Senior CQ Specialist, Perform 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.
• 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
• 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 an ability to multi-task across projects and activities.
• Demonstrate proficiency in computerized systems (Experience and use of LIMS, Empower are plus).
• Demonstrated ability to troubleshoot analytical methods
• Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter as wells as more advanced techniques, i.e. GC, HPLC, AA, FTIR, etc.
• BS/MS in Chemistry or BS Science Degree
• At least 4 years analytical laboratory experience in a GMP regulated environment or 3 years for MS/PhD
• Experience in parenteral drug product pharmaceutical manufacturing is plus.
• Successful hands-on analytical testing experience in a GMP environment.
• Must be Certified Fellow Employee trained and have Control Drug Agent status
Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives
Last Date to Apply for Job: July 31, 2017
Grade: Legacy Hospira - Grade 07
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.