Business Support 3

ROLE SUMMARY

The Rochester Business Support 3 is responsible for the Document Control & Training processes at the site. This position is focused on ensuring documentation and training processes conform to cGMP and regulatory requirements as well as Pfizer approved procedures. The Business Support 3 is responsible for the maintenance of the cGMP-controlled documentation systems PDOCs and Training System PLS. Providing the various departments, the documentation and training support that is required to perform cGMP activities. Other responsibilities include Change Management, Standard Operating procedures (SOPS) updates, Compliance gap analysis, Project work and data reporting for the PDOCs and PLS systems. The individual will assist in the day-to-day Documentation and Training System responsibilities within Pfizer complying with company and regulatory requirements.

ROLE RESPONSIBILITIES

• Performs tasks to facilitate the Site Documentation Control and Training Programs.
• Performs document control functions, including admin document and training login accounts, generation, tracking, processing, review, distribution, release and archiving of documents.
• Coordinates the revision, review, and approval of documents in PDOCs and PLS systems.
• 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.
• Monitor and provides follow up with department meetings on document target completion dates for the Periodic Review Program.
• Maintains and distributes SOP, Forms, and logbook reconciliation for all departments.
• Assists in the Annual Curriculum Review for site.
• Completes continuous improvement and project work for documentation and training systems.
• Provides support for Documentation and Training systems for regulatory, corporate, and vendor audits.
• Supports documentation and training 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

Must-Have

• 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.
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies. Ability to act decisively in real time and communicate/defend decisions with applicable areas of the organization.
• Strong analytical, critical thinking and problem-solving abilities.
• Understanding of cGMP guidelines outlined in CFR. Knowledge and demonstrated ability to apply Pfizer Quality Standards to ensure local practices and procedures reflect these requirements. Independently generates/maintains SOPs, Batch Records, Forms, Logbooks, technical reports, validation/qualification documents, project plans, etc.
• Associate degree in a scientific discipline, preferred.

Nice-to-Have

• Minimum 2 years of experience is with document control/management in a regulated industry (pharmaceutical, biotech or medical device), preferred

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

Must not have a Penicillin allergy. Schedule is on 1st shift, Monday - Friday.

Other Job Details

• Last Date to Apply for Job: May 24, 2022
• Eligible for Relocation Package: NO

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.

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