Pfizer Senior CQ Specialist 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
PHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements)
Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity. Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
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
(not all roles will have non-standard work schedule travel, or environment requirements)
Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.
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.
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.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Last Date to Apply for Job: July 31, 2018
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.