11 days old

GTx QA Sr. Validation Associate

Pfizer
Sanford, NC 27330
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**ROLE SUMMARY**

The position will support the Pfizer Sanford, NC Gene Therapy Quality Operations department by performing Quality Assurance activities associated with clinical and/or commercial product. Key responsibilities are performing Quality final authorization/approval/release of cGXP documentation/equipment/processes; plans and executes complex projects; suggests improvements and conducts continuous improvement activities; and provides guidance/coaching to less experienced colleagues. This role will have a primary focus in providing quality oversight for activities associated with facility, equipment, laboratory and process verification/validation/qualification and automation.



The individual should be able to demonstrate the following:



+ Has sufficiently broad depth of knowledge of GXPs to be a key contributor or may be able to lead continuous improvement to a process or improve business efficiencies.

+ Can identify and implement new processes and programs for quality improvement.

+ Contributes to the interpretation of cGXPs for the commercial and clinical environment.

+ Quality lead on large projects.

+ Independently review working instructions/global procedures for technical content across multiple subject areas, with reference to applicable GXPs and regulatory expectations make value-added comments. Interfaces with other parts of the organization such as Pfizer research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.

+ Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.

+ Reviews trending reports and influences /agrees actions with key stakeholders.

+ Provide guidance/coaching to less experienced colleagues.

+ Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.

+ Provides interpretation of data and reports.

+ Advises on more complex policy and procedures.

+ May lead and approve complex investigation.

+ Makes decisions that may involve complex quality and technical issues.

+ Makes decisions that may impact project progression and timelines.

+ Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas.

+ Coach/mentor other colleagues with investigations.

+ Collaborates/independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.

+ Anticipates issues and elevates them to appropriate management attention immediately.

+ Demonstrates sound judgment on decisions that may involve technical issues.

+ Able to assess internal and external compliance with applicable regulations.

+ Trains colleagues on workgroup practices within area of expertise.

+ Proactively and independently applies departmental best practices to work assignments.

+ Able to recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.

+ Routinely demonstrate a good practice of technical exchange and open communication with team members. Participates in and may take a lead in decision making process.

+ Team Involvement: Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team.

+ Manage workload to meet established timelines.



Individual should have knowledge of US, EU, and ROW cGXP, Microsoft Office applications specifically Word and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management.



Preferred experience with; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Systems, Applications, and Products (SAP), PGS Learning Solutions (PLS) and Document Management System (PDOCs)

Preferred experience with Verification/Validation document review, QA shop floor activities, batch record reviews, BOH audits.



**ROLE RESPONSIBILITIES**

Responsible for knowing, understanding and acting in accordance with cGXPs, Pfizer's values and culture.



Providing Quality Review/Oversight of site cGXP documentation related to the operation of a GMP manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.



Responsible for final authorization/approval/release of documentation/equipment/processes.



Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.



Plans and leads projects to ensure their timely completion.



Organizes and provides written and/or oral presentations of work with minimal input.



**QUALIFICATIONS**

The minimal education and experience is as follows:



+ 3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field. Ideal candidate will have experience with equipment/laboratory/process validation, qualification, verification and automation.

+ 0-3 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field. Ideal candidate will have experience with equipment/laboratory/process validation, qualification, verification and automation.



Preferred Quality experience/skills:



+ Understanding of cell based manufacturing/research

+ Understanding of QTS, SAP, LIMS, PLS, PDOCs



+ Last Date to Apply for Job: 4/8/2020 Eligible for Employee Referral Bonus



**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.



**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.



Quality Assurance and Control
Posted: 2020-03-23 Expires: 2020-05-04

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GTx QA Sr. Validation Associate

Pfizer
Sanford, NC 27330

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