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SrAssociat QualityAssurance

Pfizer


Location:
Sanford, NC
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**



The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Assurance activities associated with clinical and/or commercial product, raw materials, validation, and stability. Key responsibilities are performing Quality review/approval of clinical and/or commercial documentation for facilities/equipment/processes; plans and executes quarterly reports; suggests improvements and conducts continuous improvement activities; and provides guidance/coaching to less experienced colleagues.







The individual should be able to demonstrate the following:







+ Has sufficient broad depth of knowledge of clinical/commercial quality requirements to be a key contributor or lead continuous improvement to a process or improve business efficiencies.



+ Can identify and implement new processes and programs for quality improvement.



+ Contributes to the interpretation of cGxPs for the commercial and clinical environment.



+ Quality review/approve of Standard Operating Procedures (SOPs) with reference to applicable cGxPs and regulatory expectations and make value-added comments.



+ Quality review/approve of maintenance documentation of activities with reference to applicable cGxPs and regulatory expectations and make value-added comments.



+ Quality review/approve of equipment/facility qualification, cleaning validation and process validation documentation with reference to applicable cGxPs and regulatory expectations and make value-added comments.



+ Interface with other parts of the organization such as Pfizer research and development groups.



+ Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.



+ Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings.



+ Reviews trending reports and influences/agrees on actions with key stakeholders.



+ Review/approves maintenance activity documentation.



+ Provide guidance/coaching to less experienced colleagues.



+ Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.



+ Provides interpretation of data trends and reports.



+ Advises on more complex policy and procedures.



+ Review/approve complex investigations.



+ Makes decisions that may involve complex quality and technical issues.



+ Makes decisions that may impact project progression and timelines.



+ Collaborates/independently engages with a wide range of co-workers, customers and management within the OpU to gather input and background knowledge needed to complete assignments.



+ Anticipates issues and elevates them to appropriate management attention immediately.



+ Demonstrates sound judgment on decisions that may involve technical issues.



+ Able to assess internal and external compliance with applicable regulations.



+ Proactively and independently applies departmental best practices to work assignments.



+ Able to recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.



+ Routinely demonstrate a good practice of technical exchange and open communication with team members. Participates in and may take a lead in decision making process.



+ Team Involvement: Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team.



+ Manage workload to meet established timelines.







Individual should have knowledge of US, EU, and ROW cGXP, Microsoft Office applications specifically Word and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management.



Preferred experience with; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Systems, Applications, and Products (SAP); Document Management System (PDOCS)







**ROLE RESPONSIBILITIES**



Responsible for knowing, understanding and acting in accordance with cGXPs, Pfizer's values and our OWNIT culture. Providing Quality Review/Oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.



Responsible for review/approval of documentation/equipment/processes.



Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.



Plans and leads projects to ensure their timely completion.



Provide guidance/coaching to less experienced colleagues.



Organizes and provides written and/or oral presentations of work with minimal input.







**QUALIFICATIONS**



The minimal education and experience is as follows:



3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field



0 -3 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field







**PHYSICAL/MENTAL REQUIREMENTS**



Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.



Limited travel for the position; no more than 10% traveling.



**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







**Sunshine Act**



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: 15 November, 2017**



+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 007**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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