QA Documentation Supervisor
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.
Role is Accountable for: Ensuring all plant changes to documentation are executed appropriately and effectively according to Plant, Corporate and Regulatory requirements.
Responsible for: Direct training and supervision of documentation personnel who perform the review and processing all site documentation both paper and electronic. SOPs, TCPs, Monographs, and Batch Records for the plant operations. Maintain colleagues time and attendance records. Oversee the Periodic Review process for the site. . Ensures requirements for Good Documentation Practices (GDP) and compliance to site and corporate procedures are met with all GMP documents processed through the documentation center. Ensure site and corporate guidelines for storage of documents in the salt mine are followed. Manage logbook process Interacts with all level of the organization Successfully assists site colleagues in the correct process of document creation, revision and obsoletion of GMP documents. Required to make technical decisions associated with issue resolution and compliance of data contained within site GMP documents Make critical and quality decisions to resolve documentation issues. Ensures documentation colleagues maintain the documentation system, PDOCs, in a complaint state. Train all documentation colleagues to ensure their task are completed per site and corporate procedures and guidelines. Will be required to interface with regulatory inspectors and other auditors.
Supervise a team of non-exempt and/or exempt Quality Assurance colleagues that are responsible for documentation of site procedures.
Required to have working knowledge of site procedures, corporate guidance and regulatory expectations pertaining to GDP, data integrity and documentation practices and processes.
Collaborates with all departments at the site.
SME for PDOCs system and monitors activity within the system
Creates and delivers PDOCs training for all levels of access
Quality decision making associated with issues with in the documentation process for the site
Trained and has access to gQTS for Change Managements, CAPAs and Investigations (Events)
Mentor direct reports
Bachelor’s degree required, Science degree preferred
Bachelor's Degree in Engineering, Business or Science with a minimum of 3+ years of experience and 1+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment
Leadership experience preferred
Project management experience preferred
Working knowledge of Good Documentation, Data Integrity, Regulatory requirements for maintenance of a Documentation System
Critical thinking skills
Ability to independently make Quality decisions
Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations or data analysis.
Ability to multi-task and work in a fast paced environment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Possible weekend work
- Eligible for Relocation Package
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 ActPfizer 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 EligibilityPfizer 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