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QA Specialist

Pfizer


Location:
Kalamazoo, MI
Date:
01/10/2018
2018-01-102018-02-10
Pfizer
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Job Details

**ROLE SUMMARY**



This posting is for a position in the QA Drug Product team providing real time quality impact support (including off shift and weekends) for the Drug Product processing area. This colleagues responsibility is to ensure timely release of conforming Drug Product as well as timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).







**ROLE RESPONSIBILITIES**







+ Independently provide Real Time Quality impact assessments and decisions on Drug product issues



+ Ability to handle complex and detailed situations



+ Accurately assess consequences of decisions



+ Accurately assess potential Regulatory impacts on a Global basis



+ Immediately escalate issues with potential market or stability impact



+ Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.



+ Evaluates data and releases Pfizer produced products that conform to corporate, customer, and regulatory standards. Maintains associated test plans.



+ Evaluates product data annually and writes and/or reviews Annual Product Review Reports for approval by management.



+ Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary



+ Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations



+ Lead/Participate in QRM assessments that gain approval through Site and Area QO Management



+ Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc... as appropriate



+ Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts



+ SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns



+ Participates in internal GMP audits



+ Provides product knowledge and support for regulatory deficiency responses, regulatory annual reports, and the development of other regulatory submission packages.



+ Maintains knowledge of product filings to support inquiry responses from internal and external customers.







Effectively communicate complex technical issues to all levels of Management (including outside of Quality)







**QUALIFICATIONS**



Education: BS in Chemistry, Microbiology, Engineering or other science related discipline



Experience: Minimum 5 years pharmaceutical experience. Quality Assurance experience required. Experience at a drug product manufacturing site with deviation and lot release support.







**PHYSICAL/MENTAL REQUIREMENTS**



Office position with time in the production environment.



Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.







**ORGANIZATIONAL RELATIONSHIPS**



Works closely with drug product operations, supply, laboratory, and quality operations colleagues (peers and various levels of leadership). Involvement in regulatory, line extension and life cycle teams.







**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: 1/23/18**



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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