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 operations or laboratory support, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Engineering or Operations Support activities (such as: method transfers, protocols, reports, investigations, change controls, and other activities as needed). Your expertise will help in identifying deviations from established standards in manufacturing, engineering or the QC labs. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
It is your problem-solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Independently support complex investigations in cross-functional work areas, providing sound quality assurance judgment to ensure product quality.
- Routinely provide updates to the team and management on milestones and lessons learned with complex investigations as required.
- Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.
- Reviews and approves protocols and reports and authors, reviews, and approves SOPs as appropriate (as required for support when necessary).
- Independently provide Quality Review and oversight of site cGXP documentation related to the support of Manufacturing, labs and Site/Engineering activities to ensure compliance with global regulatory agencies and Pfizer quality standards.
- Collaborate/independently engage with a wide range of co-workers, customers, and management within Pfizer Global Supply (and external sites as necessary) to gather the input and background knowledge needed to complete assignments.
- Anticipate issues and provide recommendations for path forward to appropriate management attention immediately.
- Provide ongoing Site-based Operations support activities, on teams, in forums & support to site customers.
- Review and approval of change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
- Ability to independently issue notifications to management for critical issues.
- Exercises judgment in resolving complex quality issues.
- Plans and executes work independently and consults with supervisor as needed, providing a recommendation for a solution.
- Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
- Mentor junior quality colleagues on best practices and complex problem resolution to quality issues and CAPAs.
- Lead and drive continuous improvement activities.
- Support the development of country quality strategic initiatives based on risk and business needs, in close collaboration with key stakeholders.
- Lead continuous inspection readiness for Quality Assurance.
- Proactively and independently applies sound technical judgment to resolve quality issues.
- May be required to assist with batch record review and disposition activities.
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
- GMP manufacturing/quality experience
- Current Good Manufacturing Practices (cGMP) experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
- Proactive approach and strong critical thinking skills
- Strong collaboration, relationship management, and interpersonal skills
- Excellent written and verbal communication
- Advanced computer skills in MS Office applications and experience operating within quality enterprise systems
Nice-to-Have
- Biology, Chemistry, Engineering, or related Technical Physical Science field of study preferred
- Master's degree
- Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
- Previous experience in QA strongly preferred.
- Previous experience in QC, Manufacturing and/or Engineering preferred.
- Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP and Pfizer document repositories.
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to be present at the Andover site routinely as required.
- Must be able to gown and enter the suite
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position is first shift Monday through Friday. Some occasional off hour (night/weekend/holiday) support may be required to support staff and operations.
OTHER JOB DETAILS
- Last Date to Apply for Job: May 29, 2023
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
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.
Quality Assurance and Control
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