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Sr Sci I

Pfizer


Location:
Andover, MA
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

The qualified candidate will provide non-testing support for multiple MAb and contracted products in a cGMP quality control analytical (QCA) laboratory. This support includes oversight of method transfers,validations and qualifications in support of process validation readiness. The position includes writing transfer documents and regulatory submissions.The candidate will oversee transfer activities, participate in site transfer teams, track testing and timelines.







Represent QCA on cross-functional teams. Collaborate with Manufacturing, EVM (Engineering, Validation and Maintenance), Quality Assurance and STS (Site Technical Services), as well as with Pharmaceutical Sciences personnel on site. Participate in network teams as appropriate. Support the QC manager and act as backup as needed.







Key responsibilities:







+ Writing and reviewing of technical documents, transfer plans, test methods, validation protocols and reports in support of new product transfers, co-validation, process validation, qualification, verification Investigations, change controls and regulatory submissions.



+ Support lab testing: review data and documents for compliance and accuracy.



+ Represent Quality Control Analytical in cross functional and site product meetings.



+ Support Change controls and Investigations and new instrument validation.



+ Assist in assay troubleshooting and look for CI opportunities/method improvements.



+ Work on team projects as needed.



+ Responsible for cGMP compliance and inspection of labs. Review and approval of documentation associated with cGMP testing, transfer documents, investigations, change controls, and technical reports.



+ Point of contact for transfer teams. Collaborate with site functional areas and customers to support site goals and objectives and transfer timelines.







Meet all timelines and deliverables in the support of the plan of record.







**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.







**Additional Offer Details:**







+ Last Date to Apply for Job: November 8, 2017



+ This job is Pfizer/Exempt (US/PR) Grade: 10







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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