21 days old

Senior Associate, Quality

Collegeville, PA 19426
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The Sr. Associate, Documentation is responsible for determining the SOPs and other critical policy/process documents that need to be developed and/or updated and establish their prioritization. Additionally, the individual will support additional critical RQA processes and procedures.


+ Work with the process team leader, determine the SOPs and other critical policy/process documents that need to be developed and/or updated and establish their prioritization

+ Manage the development and maintenance of RQA SOPs and procedures including the following activities:

+ Responsible for the management of procedural documentation creation and revision; serve as the primary author of local work instructions and supporting documents

+ Partner with internal and external stakeholders, including subject matter experts and RQA leadership, to coordinate and monitor the internal review and approval process of internal documentation to ensure timely revision, change control and compliance with Pfizer standards

+ Liaise with the Center of Excellence SOP and Training group to ensure that global policies are met and executed

+ Maintain document management system inclusive of process and technology enhancements

+ Serves as the communications lead for all process changes and communications

+ Partner with colleagues/contractors/managers to ensure successful onboarding and off-boarding transition and documentation

+ Manage the audit certificate process including the collection of audit data, managing the review and approval process and filing in the TMF

+ Coordinate audit preparation and planning activities

+ Help ensure quality of websites (e.g. SharePoint, Teams)

+ Escalate audit questions and issues as appropriate

+ Manage and coordinate special audit projects as required


**Must Have:**

+ Bachelor's degree required

+ 3+ years of relevant experience

+ Excellent project management, presentation development and communication skills

+ Demonstrated ability to handle multiple tasks simultaneously, respond to tight timelines, and meet frequently changing priorities

+ Customer-oriented approach and ability to effectively work in cross-functional teams

+ Proven experience in contributing to the planning and implementation of processes to optimize business operations

+ Strong problem-solving skills and ability to work in matrixed environment

+ Strong collaboration, relationship management, and interpersonal skills

**Nice to Have:**

+ Advanced degree strongly preferred

+ Continuous improvement expertise, a plus

**Other Job Details:**

+ **Last Date to Apply for Job: June 22, 2021**

+ **Additional Locations: New York City, NY; Collegeville, PA; Groton, CT; Peapack, NJ; Tampa, FL**

**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: 2021-06-02 Expires: 2021-07-17
Sponsored by:
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Senior Associate, Quality

Collegeville, PA 19426

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