Sign In
 [New User? Sign Up]
Mobile Version

APQR Technical Reviewer

Pfizer


Location:
McPherson, KS 67460
Date:
12/07/2017
2017-12-072018-01-07
Pfizer
Apply on the Company Site
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

**ROLE SUMMARY**



Performs statistical review and trend analysis for the Annual Product Quality Review program. Analysis to include assessment of manufacturing processes and associated investigations, corrective/preventive action, Field Alert Reports (FARs), and critical parameters related to the product to identify any actions required to maintain an effectively controlled manufacturing process.







**ROLE RESPONSIBILITIES**



Identify and track trends associated with Annual Product Quality Review (APQR) for all commercial products. Duties will include:







+ Identifying manufacturing investigation trends related to the product and determining if adequate corrective and preventive action was taken.







+ Assessing effectiveness of corrective and preventive actions within the APQR scope.







+ Perform statistical analysis and graphing of critical parameters for trend identification.







+ Perform analysis of starting materials for all product lots (API, excipients, components).







+ Reporting of FARs associated with each APQR and effectiveness verification of actions documented within the FAR.







+ Performing a holistic analysis of all APQR data inputs to identify emergent adverse trends amongst various quality systems (ex. manufacturing investigations, complaints, analytical data, etc.) and recommending appropriate corrective/preventive action







+ Other duties as assigned







**QUALIFICATIONS**







+ Attention to detail and must be able to work independently.



+ Ability to understand and apply basic statistical concepts for trend identification and analysis.



+ Ability to take a systematic approach to understanding the interaction between Quality Systems



+ Bachelor's degree in science, math, or business preferred, or 5 years applicable experience in quality functions of pharmaceuticals industry.



+ Basic computer skills with Microsoft office (Word, Excel, Access) required. Experience with statistical software preferred.



+ Good communication skills for written reports.



+ Must be able to work well with others, across department lines.



+ Experience in multiple pharmaceutical quality areas preferred.







**PHYSICAL/MENTAL REQUIREMENTS**



Considerable mental/visual concentration, including long periods of sitting and typing and strict documentation requirements. Must be able to lift 20 lbs. with occasional bending and reaching. May involve frequent travel around the plant.







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



No travel requirements are necessary for this position. The work schedule is for first shift, but the hours can be flexible.







**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: December 20, 2017**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]