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Quality Project Specialist, Pfizer CentreOne Quality 1st shift 8am to 5pm

Pfizer


Location:
Rocky Mount, NC
Date:
01/09/2018
2018-01-092018-02-09
Pfizer
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Job Details

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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.







The Pfizer CentreOne Quality Project Specialist is responsible for quality activities related to the launch of new products including customer service / support / maintenance of Quality programs related to the development and manufacture of contract manufactured products for Pfizer CentreOne (PC1) customers including establishment of Quality Technical Agreements (QTA's). Responsible for supporting / assisting PC1 Program Managers with PC1 customer quality concerns/issues/events for both new and existing products including QTA's, studies, investigations, customer complaints (marketed &; non-marketed), change controls, and validations. This includes review of exception documentation, batch record documentation as deemed necessary and validation documentation. Supports PC1 business/quality reviews and participates in quality councils between all parties (customer and corporate Pfizer CentreOne). Supports / assists with tracking and release of products manufactured for the Pfizer CentreOne business.







Write and maintain customer Quality Technical Agreements (QTA's).



Supports site during customer visits, Quarterly Business/Quality Reviews, and audits / inspections.



Monitor, track, and present quality metrics; support strategies to continuously improve.



Support and review applicable studies, exceptions/investigations, customer complaints, change controls, and validations for impact to customer's products.



Liaison between site and PC1 customer for all quality-related issues. Support / respond to customer requests / concerns. Coordinates with site SME's / areas of responsibility to develop appropriate actions as appropriate to maintain customer centricity and ensure customer quality harmonization with the site.



Attend &; support internal meetings related to customer initiatives.



Participate in routine meetings for customer interface / support / centricity.



Communicate quality impacting issues to customers; develop mitigation strategy with customers per QTA requirements. Redact shared documents in accord with QTA to maintain confidentiality / firewall.



Support change control activities / requests for / from PC1 customers.



Provide APQR input for QTA annual review.







Minimum of 4 years of experience in the pharmaceutical industry.



Minimum of 2 years experience with batch record documentation, product and process specifications, and standard operating procedures.



Knowledge of regulations for drug and medical devices.



Knowledge and ability to interface with the FDA during inspections that impact area of responsibility.



Strong written and verbal communication skills and professionalism. Demonstrated ability to write logically and consistently when preparing protocols and reports.



Knowledge of Investigation process.



Strong social skills.



Strong customer focus.



Strong problem solving skills.



Strong organizational skills.



Proven experience with various computer software applications to track and trend quality metrics.



Ability to work and adapt in a fast pace environment.



Ability to understand commercial strategies and business applications.



Ability to take key actions and demonstrate behavioral anchors that support all Hospira core and Leadership competencies.







PHYSICAL/MENTAL REQUIREMENTS



Walks.



Climbs stairs.



Stand up to 1-2 hours.



Sit for up to 6-8 hours.



Works around moving equipment.



Wears specialized protective clothing.



Works in hearing conservation area.



Uses a computer terminal 6-8 hours/shift.







NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS



Colleague will work standard mon-fri work schedule. Start time beginning between the hours of 8 - 8:30 am and ending between the hours of 5-5:30 pm. Weekend support may be required as dictated by project schedule or customer need.







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.







Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.







Legacy Hospira grade 16







+ The Pfizer CentreOne Quality Project Specialist is responsible for quality activities related to the launch of new products including customer service / support / maintenance of Quality programs related to the development and manufacture of contract manufactured products for Pfizer CentreOne (PC1) customers including establishment of Quality Technical Agreements (QTA's). Responsible for supporting / assisting PC1 Program Managers with PC1 customer quality concerns/issues/events for both new and existing products including QTA's, studies, investigations, customer complaints (marketed &; non-marketed), change controls, and validations. This includes review of exception documentation, batch record documentation as deemed necessary and validation documentation. Supports PC1 business/quality reviews and participates in quality councils between all parties (customer and corporate Pfizer CentreOne). Supports / assists with tracking and release of products manufactured for the Pfizer CentreOne business. Eligible for Relocation Package







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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