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QA Technical Specialist

Pfizer


Location:
New York, NY 10029
Date:
04/17/2018
2018-04-172018-05-18
Pfizer
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Job Details

**POSITION SUMMARY**



Under routine supervision the QA Technical Specialist Stability & SOP will perform activities including but not limited to: Coordinate and Maintain the Stability program for the site, review and approved Standard Operating Procedures. Review and audit of validation/ qualification /verification activities for the laboratory operations.







**ESSENTIAL FUNCTIONS:**







+ Responsible for the evaluation of the Stability Data to notify any trend. Document the failures or trends using stability alert reports (as applicable).



+ Performs the stability studies initiation process including stability samples handling for initiation.



+ Receives and audits the stability data (raw data and tables) of current and in progress stability studies (as applicable).



+ Responsible of open, update and close stability studies on ScienTek (as applicable).



+ Review and approved Standard Operating Procedures.



+ Review and audit of validation/ qualification /verification activities for the laboratory operations.



+ Responsible of review and approve method validations.



+ Other functions can apply as deemed necessary by Quality Management.



+ Evaluate protocols and stability reports for correctness in support of QO Director or designee.







**PRINCIPAL WORKING RELATIONSHIPS**







+ Inside the Company: Maintain good communication with all site departments.



+ Outside the Company: Maintain good communication with SLS Team, GMC, COQA, peers at other companies and consultants.







**QUALIFICATION REQUIREMENTS:**



Education:







+ BS Degree in science (Chemistry, General Sciences, Biology) or EngineeringExperience:



+ At least five (5) years of experience in the pharmaceutical industry, Quality Operations areas (QC, QA, Compliance).



+ Good Statistical knowledge and experience including regression analysis **OTHER REQUIREMENTS:**







+ Knowledge of GMP, NDA, CMC, DEA/FDA regulations.



+ Experience handling and/or supporting regulatory inspections



+ Proven organization skills are required.



+ Excellent communication skills (oral, written and reading) in English and Spanish.



+ Proficient in computer software's such as Microsoft Office, Minitab.



+ Ability to handle several priorities simultaneously.







**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:** April 27, 2018



+ 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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