QA Documentation Coordinator

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 flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.  

What You Will Achieve 

In your role, you have the all-important task of preparation and review of required documentation, such as Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) manuals. You will be relied on to prepare procedure manuals, quality control manuals, engineering documents, manufacturing instructions and change authorizations in accordance with company policy and government regulations. Your skills will help you implement related documentation systems, propose change control processes and coordinate the review of procedures and forms. You will also provide input on quality control procedures and R&D documentation. 
 

As part of the business support team, you have comprehensive knowledge and skills in your area and understand how related areas impact it. You take initiative to establish a connect with other projects and represent your department on cross-functional teams. You are proactive in sharing knowledge and expertise with others in your work group. You are seen as someone who promotes teamwork and always motivates others to achieve team objectives. 
 

It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.  

How You Will Achieve It  

ROLE RESPONSIBILITIES

• Assists in Process Improvement Projects for the Documentation program including PQS requirements, RQA Actions, and PDOCs system updates.
• Monitor and provides follow up with department meetings on document target completion dates for the Periodic Review Program.
• Performs document control functions, including admin document login accounts, generation, tracking, processing, review, distribution, release and archiving of documents.
• Coordinates the revision, review, and approval of documents in the PDOCs system.
• Organizes and ensures accurate and reliable filing of all paper-based documents as well as electronic copies (e.g., MSB Digital Signature).
• Maintains processes for SOPs, master batch records, specifications, test methods, OJTs, validation protocols/reports, technical protocols, reports, and other GMP documents.
• Maintains and distributes SOP, Forms, and logbook reconciliation for all departments.
• Assists in the Annual Curriculum Review for site.
• Responsible for creation and distribution of Annual LUMAC Logs.
• May support continuous improvement and project work for documentation and training systems.
• Provides support for Documentation systems for regulatory, corporate, and vendor audits.
• Supports documentation metrics for the site’s monthly Site Quality Review Team/Management Review meeting.
• Conduct gap assessments on site standards, policies, and procedures to ensure they are aligned with global Pfizer Quality Standards.
• Author and revise various quality documentation (SOPs, CAS Reports, Change Controls, CAPAs/Commitments, Risk Assessments, etc.) in QTS system.
• Role will require after hour and weekend support from time to time.

Qualifications  

Education: 

• Applicant must have a high school diploma with at least four years of relevant experience

Experience:  

• Must be skilled in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat.

• Must be well-organized and have the ability to maintain attention to detail while executing multiple tasks
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
• Ability to effectively build and maintain relationships, communicating and interacting with multiple departments.
• Managing timelines to meet corporate goals.
• Demonstrated ability to work in a productive and collaborative cross-functional manner.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.

Nice-to-Have 

• Strong reading comprehension and proofreading skills. 

• Strong organizational skills.

PHYSICAL/MENTAL REQUIREMENTS

The position will require work at desk and periodic distribution and filing of documents.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Role will requir