16 days old

Change Control and Documentation Specialist

Pfizer
Rocky Mount, NC 27804
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**ROLE SUMMARY**



The Documentation Specialist Level 7 **,** Prepares and reviews required documentation for the Chemical Quality Department. Implements change control processes using the Global Quality Tracking System (QTS) and PDOCs. Coordinates the review and revision of procedures, specifications, and forms.



**ROLE RESPONSIBILITIES**



+ Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.

+ Follows procedures at all times, adopting cGMP, cGDP practices.

+ Edit and Write Standard Operating Procedures and other documentation as needed

+ Initiate and facilitate change requests in PDOCS and the Global Quality Tracking System (QTS)

+ Reconcile change requests from initiation to closure

+ Review and approve documents in the change control system



**QUALIFICATIONS**



**Must-Have**



+ Minimum of 5 years' experience in a science related position, pharmaceutical industry preferred.

+ 3 years' experience in a manufacturing site.

+ 3 or more years in a pharmaceutical facility.

+ BS degree in science field is required

+ Excellent verbal and written communication skills and attention to detail.

+ Proficient with Microsoft Office.

+ Experience in SAP, QTS, DMS, PDOC system and Change Control preferred

+ Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.

+ Demonstrated ability to write logically and consistently.

+ Strong critical thinking and problem solving skills.

+ Resourceful and innovative approach.

+ Ability to work cross-functionally with a diverse team.



**Nice-to-have**



+ Experience with Compendial Monographs and General Chapters



**PHYSICAL/MENTAL REQUIREMENTS**



Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Shift is 1st, Monday - Friday from 8am to 5pm typically. There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives.



**Other Job Details**



+ **Last Date to Apply for Job: June 10, 2021**

+ Eligible for Relocation Package: NO

+ Eligible for Employee Referral Bonus: YES

+ \#LI-PFE



**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
Posted: 2021-05-28 Expires: 2021-06-28
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Change Control and Documentation Specialist

Pfizer
Rocky Mount, NC 27804

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