Sign In
 [New User? Sign Up]
Mobile Version

QA Technical Specialist


New York, NY 10029
Apply on the Company Site
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details


Responsible for review and audit of validation/ qualification /verification activities including but not limited to manufacturing, packaging, utilities, facilities and systems. Actively participate in the definition of validation/qualification strategies for the product being transferred from other sites.


+ Review and approve Commissioning Documentation , Installation Certification,

+ Operational Qu alification and Performance /Process Qualification) and Verification.

+ Review and approve Master Batch Records which includes manufacturing and packaging.

+ Review and approved Standard Operating Procedures.

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

+ Responsible for the coordination of Change Requests for Qualified Production Records, Equipment, Systems, and Facilities (CR) by reviewing CR, assigning tracking number, safekeeping original CR, and closing-out completed CR.

+ Alert Management of compliance issues.

+ Performs special project assignments as required.


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.


+ 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).


+ 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.

+ Ability to handle several priorities simultaneously.

+ Technical Skills (Process Validation, Serialization, Cleaning Validation, Computer Validation)

**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.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]