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QA Technical Specialist

Pfizer


Location:
New York, NY 10029
Date:
04/12/2018
2018-04-122018-05-13
Pfizer
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Job Details

**POSITION SUMMARY**



Responsible for the issuance of the Annual Product Record Review (APRR), perform activities including but not limited to preparation of the yearly schedule, gathering of the complaint, analytical and in-process data, product changes. Perform statistical analysis of the laboratory analytical and in-process data.







**ESSENTIAL FUNCTIONS:**







+ Issues Annual Product Record Review (APRR) for all Pfizer, Vega Baja site products as established in yearly schedules.



+ As part of the APPR, evaluate data and make recommendations as needed.



+ Prepare trending studies in order to avoid quality problems and make recommendations for corrective actions.



+ Be able to work in QA or QO depending on business needs and/or reassignment of responsibilities.



+ Support in any other activities as required by the Supervisor.



+ Alert Management of compliance issues.



+ Performs special project assignments as required.







**PRINCIPAL WORKING RELATIONSHIPS**







Inside the Company: Maintain good communication with all site departments



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







**QUALIFICATION REQUIREMENTS:**







+ Education:



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



+ Experience:



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



+ Good Statistical knowledge and experience working with manufacturing and/or packaging process.







**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.



+ Technical Skills







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: April 25, 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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