Quality Assurance Associate III, Validation
Location
Bothell, WA | United States
Job description
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 As a QA Associate III specializing in Validation Oversight, you are responsible for quality oversight of the implementation and maintenance of qualified equipment systems. The responsibilities include reviewing and approving change controls, validation documentation, and periodic and re-qualification reviews; participating on cross-functional teams; answering questions from internal staff; and executing on established procedures.
How You Will Achieve It - Provide Quality Oversight on validation projects for simple to moderately complex systems to assure systems are fit for purpose in GMP operations, including:
- Support customers and answer questions on assigned projects
- Perform impact assessments on and approve system change controls
- Collaborate on or approve validation lifecycle documentation for small to medium systems
- Collaborate on or approve system operation, administration, and use operating procedures
- Perform or approve investigations on deviations and incidents in small to medium systems
- Contribute to milestones associated with specific projects
- Write/revise, review, collaborate on, and approve program standard operating procedures; and ensure documents reflect current practices
- Provide support for audits and inspections, as needed
- Represent the functional area on cross-functional teams or teams with external parties
- Own simple continuous improvement activities
- Other duties as assigned
QUALIFICATIONS Must-Have - Bachelor's degree in relevant field; or Associate's degree +2 years of relevant experience in the biotech or pharmaceutical industry
- 5+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
- Working knowledge of cGMP, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
- Working knowledge of current industry practices and standards
- Advanced expertise with Office 365, especially Excel
- Experience with applicable software (e.g., electronic Validation Management System, electronic Document Management System.)
- Excellent written and oral communication skills
- Demonstrated problem-solving skills and techniques commensurate with job level
- Ability to manage routine and non-routine workload with minimal oversight
Nice-To-Have - Experience with process and product validation.
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality.
- Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure.
PHYSICAL/MENTAL REQUIREMENTS - Requires routine sitting, standing, walking, listening and talking
- Acute mental and visual attention at all times
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must be able and willing to work outside of typical business hours to support the business, which may include weekends and holidays.
Other Job Details: - Last day to Apply: March 20th, 2024.
- Eligible for Relocation Assistance: NO
- Work Location Assignment:On Premise
The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
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