QA Validation Senior Associate
QA Validation Senior Associate
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Job Description
Use Your Power for Purpose
Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative flexible and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development maintenance compliance or research analysis your contributions have a direct impact on patient care.
What You Will Achieve
In this role you will:
- Evaluate review and approve validation master plans protocols and reports ensuring compliance with company standards and regulatory requirements.
- Troubleshoot validation issues for equipment and performance processes providing expertise for resolution.
- Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
- Guide the writing review and approval of validation process documents and technical reports ensuring adherence to the latest Pfizer Quality Standards.
- Contribute to moderately complex projects manage time effectively and develop plans for short-term work activities.
- Manage routine Quality systems such as Change Control Quality Agreement Documentation and Investigations and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan support regulatory audits and represent engineering validation on site or network teams.
- Support product transfers new product development regulatory queries cost improvement projects and Cleaning Validation ensuring integration of validation schedules in production and participating in deviation investigations.
Here Is What You Need (Minimum Requirements)
- Applicant must have a bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience; or an associates degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
- Proven expertise in Good Manufacturing Practices
- Programming knowledge in any of the following Python SQL Pandas NumPy Tableau TensorFlow Mixpanel and Firebase.
- Familiarity with information systems such as Global Document Management System System Application & Products and Quality Tracking System
- Strong working knowledge in Microsoft Office Suite
Bonus Points If You Have (Preferred Requirements)
- Strong technical knowledge with validation/qualification of pharmaceutical processes equipment utilities facilities and/or computer systems
- Experience with sterile products and medical devices
- Experience in regulatory audits and compliance
Physical/Mental Requirements
- Excellent verbal and written communication skills
- Ability to work independently and in a team environment
- Strong analytical and problem-solving skills
- Strong organizational and time management skills
- Ability to mentor and guide other colleagues
Non-Standard Work Schedule Travel or Environment Requirements
- This role is standard day Monday through Fridaywork shift.
Other Job Details:
- Last day to Apply: July 10th
- Eligible for Relocation Assistance: No
- 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 providers 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.
Required Experience:
Senior IC
Employment Type
Full-Time
