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Sr. Specialist QO


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Job Details


This posting is for a position on the Brentwood QA team providing real time quality impact support (including off shift and weekends) to all Aseptic Poduction Quality issues spanning the Meridian Medical Technologies Aseptic Processing, Prep / Manufacturing, Filling Operations. The colleague will need to effectively work/communicate with key stakeholders and peers to ensure timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).


+ Independently provide Real Time Quality impact assessments and decisions (24/7) on all Aseptic Product Issues spanning Prep / Manufacturing, sterilization, filling

+ 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.

+ Participates in and leads QAR Gembas with customers and peers

+ Effectively leads/facilitates/participates/completes cross-functional team investigations for Field Alerts and Significant Deviations and when applicable aids in drafting of Area Quality Review summaries

+ Utilize tools such as Method 1, Human Error Reduction (HER), & Solution Tree in the course of the investigations

+ 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

+ Propose and implement improvements in the Deviation and/or Floor Support operations

+ Independently assess a wide range of Change Control activities (Protocol development, SOP and Batch Record 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 QASA audits

+ Ability to represent QA Team Leaders/Managers when needed, including ability to approve QARs as QA Managers

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


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

+ Experience: Minimum 7 years pharmaceutical experience. Quality Assurance experience required. Experience at an injectibles drug product manufacturing site with deviation support preferred.

+ 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.

+ Analytical - Collects and researches data; analyzes information skillfully.

+ Technical Skills - Excellent knowledge of manufacturing operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status.

+ Oral Communication - Listens carefully and gets clarification. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel.

+ Team Work - Contributes to building a positive team spirit.

+ Written Communication - Writes clear, accurate and concise technical and non-technical documents.

+ Diversity - Shows respect and sensitivity for personal and cultural differences.

+ Interpersonal - Interfaces with management and non-management employees in manufacturing, packaging, Inspection, engineering, pharmaceutical technology, regulatory affairs, quality assurance and laboratories

+ Ethics - Works with integrity and ethically. Maintains confidentiality.

+ Organizational Support - Supports organization's goals and values. Willing to work together to achieve a common goal.

+ Adaptability - Able to deal with frequent change, delays, and/or unexpected events.

+ Dependability - Completes tasks on time or notifies appropriate person of impending delays with an alternate course of action.

+ Innovation - Meets challenges with resourcefulness.

+ Judgment - Exhibits sound and accurate judgment.

+ Professionalism - Treats others with respect and consideration regardless of their status or position.

+ Quality - Produces analytical work of high quality. Looks for, and suggests ways to improve and promote quality.

+ Safety and Security - Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements.

**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.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

**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: February 16, 2018** Eligible for Relocation Package - Yes

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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