What are the responsibilities and job description for the Quality Systems Validation Analyst position at Pfizer?
Power for Purpose
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 this position, you will be joining our Quality Control department. The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with System Administration, Computer System Validation, and Validation Plan management.
- This position requires the demonstrated capability to lead/provide strategic direction to DI validation remediation projects (for example, lab system upgrade projects) by defining project solution, strategies and insuring effective implementation and delivery as part of the overall project execution plan.
- Key responsibilities are performing Data Integrity (DI) assessment of validation projects and then leading/managing the resulting remediation activities (for example, System upgrade project). This includes implementing DI control strategies (both technical and procedural controls) in the lab and influencing the DI/Compliance culture across the QC Organization.
- Additional responsibilities include providing support during board of heath audits and internal audits related to both the site DI Program and to all Quality Lab Data Systems.
- Also, must create, own and maintain QC validation documentation (e.g. Validation Project Plans, Electronic Records and Electronic Signature assessments, IOPQ, and Summary Reports).
- Additionally, performing change controls for QC document revisions, creating/reviewing/executing/approving activates for GMP tasks/activities associated with maintaining compliant Computer Systems Validation systems. Participating in PNR and investigations of events, acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations.
How You Will Achieve It
- Acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely.
- Recognized as a Computer System Validation Subject Matter Expert or that supports audit and investigations, reviewing/approving technical content to ensure compliance to regulations and Pfizer policy and standards.
- Recognized as a ‘go-to” person for computer system validation and having extensive technical knowledge of lab data systems and the related instrumentation used within QC.
- Independent thinker with strong organizational skills, thinking from both a tactical and strategic basis for site-based projects or global programs (i.e. DI global initiatives, and/or global interfaces).
- Demonstrated process understanding to drive troubleshooting and optimization using automation tools and system technology.
- Collaborate with site and off-site Digital colleagues to troubleshoot issues and to develop and deliver innovative solutions, best practices and technical guidelines.
- Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines.
- Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve or independently resolves complex issues.
- Applies discipline’s principles, appropriate procedures, and leadership skills to develop action plans and contributes to executing toward individual, team, and project goals.
- Expertly solving highly complex problems and solving situation dependent multifaceted problems using even only ambiguous information.
- Receives feedback well from management and other colleagues, grows self utilizing feedback and takes accountability for actions and personal development.
- Collaborate/independently engage with a wide range of co-workers, customers and management within the Network to gather the input and background knowledge needed to complete assignments.
- Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior.
- Good judgment and correct decision making based on expert knowledge of Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations.
- Decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, and site.
- Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, team, department, or Network goal/deliverable is off schedule.
- Delivery on large and complex high business impact projects/activities/changes.
- Able to identify and seek out external resources to build or enhance understanding of Computer System Validation; supports training of staff; mentoring and coaching junior colleagues.
- Displays strong investigative or technological orientation with independence for design of projects and able to make significant independent contributions to the implementation new systems.
- Uses other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes.
- Contributes to site and Network Quality Operation related strategies and decisions Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation, Empower experience, Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Labs; project management tools including stakeholder management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
Here Is What You Need (Minimum Requirements)
- Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0 years of experience; OR an Associate's degree with 6 years of experience; OR a High School diploma (or equivalent) and 8 years of relevant experience.
- Pharmaceutical industry experience (highly preferred)
- Experience in preparing and participating in audits and inspections
- Experience in validating computerized system GMP
- Excellent project management skills.
- Experience driving critical projects to completion within agreed upon timelines.
- Excellent oral, written and interpersonal communication skills.
- Knowledge of laboratory analytical computerized systems validation and qualification.
Non Standard work schedule, travel or environment requirements
- In this role, you will be a part of a dynamic team, working in a fast-paced and innovative environment.
- Your expertise will be instrumental in driving our commitment to quality and integrity.
- At Pfizer, we value your dedication and hard work, and in return, we offer a supportive and inclusive work culture, along with opportunities for professional growth and development.
Other job details
- Last day yo apply: February 6th, 2025
- No relocation support available
- Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Salary : $80,300 - $133,900
