Document Support Specialist

Description

Use Your Power for Purpose

At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care.

What You Will Achieve

In this role, you will:

• Lead the creation, review, and revision of documents (SOPs, forms, jobs aids, training material, batch records, etc.) and other manufacturing department documents. 

• Work with production operations technicians and supervisors to understand the objective of each document to ensure that all documents contain the required content. 

• Interpret information and organize it properly for accuracy, readability, and formatting, while ensuring the proper grammar and spelling is used in all documents. 

• Perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures.

• Edit and format incoming requests for new or revised manufacturing documents and assist in tracking each revision through the approval process.

• Collects and analyzes the information necessary to complete the creation and revision of forms, compound records, and batch records.

• Reviews the impact of the proposed changes with regards to other support documents.

• Support the development of new and revised documents, including suggestions for suitable terminology, content, and format while ensuring that site policies comply with corporate guidelines.

• Participate in the review of Standard Operating Procedures, batch records, compound records, forms and other related GMP documents. 

• Assist in maintaining control of documentation to include accurate document history and change revision documentation.

• Coordinate the issuance, tracking, and review of batch records and other controlled documents to ensure target product-based cycle times are met. 

• Support the reconciliation and changeover of controlled prints.

Here Is What You Need (Minimum Requirements):

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

• Strong interpersonal communication and problem-solving skills.

• Ability to learn and navigate document control and e-systems to facilitate document routing and approval.

• Ability to effectively proofread documents prepared by self and others to ensure content and formatting accuracy.

• Ability to write clearly and concisely with strong English background with excellent grammar, good writing skills, and knowledge of sentence structure.

• Ability to translate verbal guidance into precise operating instructions.

• Ability to learn and understand pharmaceutical processes to design related SOPs.

• Proficiency in Microsoft Office Suite, Adobe Acrobat, and other computer skills.

Bonus Points If You Have (Preferred Requirements):

• Prior experience with electronic quality systems (ie. PDOCs, QTS, eQMS, EAMs, etc.)

• Demonstrated experience in the pharmaceutical industry

• Robust knowledge of local manufacturing processes and procedures

PHYSICAL/MENTAL REQUIREMENTS

• Role requires ability to gown into manufacturing areas, potentially standing for several hours continuously. 

• Extended time looking at computer monitors.

• Sitting for extended periods.

Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

It is the policy of Rangam Consultants, Inc. to provide equal employment opportunities to all applicants and employees without regard to any legally protected status such as race, color, religion, gender, national origin, age, disability or veteran status. 

To find out more about Rangam and this role, click the apply button.