27 days old

Sr. Associate, Quality Systems

Pfizer
Andover, MA 01810
**Why Patients Need You**



Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.



**What You Will Achieve**



You will be a member of Pfizer's dedicated and highly effective Quality Systems Team. As a Sr. Associate, Quality Systems, you will perform lifecycle management of documents. In addition, you will have an active role in the site record retention program, including record archiving and retrieval as needed.



**How You Will Achieve It**



+ Perform life cycle management of documents such as initiation, document number issuance, approval, distribution, etc.

+ Formatting and editing documents and follow up with authors and reviewers to resolve issues. Ensure document quality and efficacy of document process flow.

+ Manages and facilitates customer requests and provide guidance on QRM document standards and processes.

+ Support the site records retention program. Performs records archiving and retrieval as needed.

+ Issues and reconciles batch records per established schedules. Works with Manufacturing and QA to ensure all batch records are accounted for.

+ Issues and reconciles Lab Notebooks, Lab Equipment Notebooks and Logbooks.

+ Write and revise internal procedures to provide closure to process gaps and/or as part of continuous improvement projects.

+ Understands electronic documentation and/or database system processes and communicates system discrepancies that may arise. Communicates issues or suggestions with Management to help rectify or improve the system efficiency

+ Participate in continuous improvement projects within department as well as outside QRM providing document management expertise.



**Qualifications**



**Must-Have**



+ Bachelor's Degree required

+ 3-5 years of relevant Quality, biopharmaceutical industry, or document management experience

+ Experience with quality records (i.e. batch records, procedures, forms, etc)

+ Proficiency with MS Word and Excel

+ Work independently

+ Be able to meet demanding timelines

+ Works well in team environment

+ Strong communication skills



**Nice-to-Have**



+ Experience with basic business analysis tools such as process mapping, decision flowcharting, DMAIC, etc.)

+ Technical writing and presentation development and delivery

+ Proficient in data integrity principles and management of electronic records



**Physical/Mental Requirements**



+ Lifting of boxes

+ Traveling between buildings on the Andover campus



**Non-Standard Work Schedule, Travel, or Environment Requirements**



+ This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise.

+ During current pandemic, work will be split between working in office and remote setting.



**Other Job Details:**



+ Eligible for Relocation Assistance: NO



\#LI-PFE



**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**



**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



\#LI-PFE

Categories

Posted: 2021-09-20 Expires: 2021-11-03

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Sr. Associate, Quality Systems

Pfizer
Andover, MA 01810

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