Quality Specialist Operations
Quality Specialist Operations
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$ 80300 - 133900
1 Vacancy
Job Description
Use Your Power for Purpose
Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and riskbased compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.
What You Will Achieve
In this role you will:
Perform onthefloor QA tasks within the manufacturing areas as needed collaborating with manufacturing and other departments to provide routine quality support and maintain inspection readiness.
Conduct onthefloor QA review of executed batch records and other manufacturing documentation to ensure adherence to site procedures regulatory standards and filing requirements.
Provide triage support across departments to address moderate quality issues ensuring timely escalation to management when necessary.
Review and approve deviations including the associated investigation reports and corrective/preventative actions.
Review and approve change controls for appropriateness completeness and alignment with quality validation and regulatory expectations.
Review and approve sampling protocols risk assessments and master batch records.
Author review and approve SOPs as appropriate for both Operations and Quality.
Assist with additional tasks including (but not limited to) Master Data management / approval GMP area walkthroughs product changeover activities.
Participate in internal audits support regulatory inspections or corporate audit activities as needed.
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 - Experience in manufacturing quality in the biotech or pharmaceutical industry.
- Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
- Proactive approach and strong critical thinking skills
- Must be able to work in a team environment within own team and interdepartmental teams
- Excellent communication and interpersonal skills
Bonus Points If You Have (Preferred Requirements)
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
- Knowledge of electronic systems such as Veeva Trackwise SAP LIMS Maximo Microsoft Office
PHYSICAL/MENTAL REQUIREMENTS
Good judgment and correct decision making based on company procedures/standards technical experience and industry guidance / regulatory requirements.
Collaboration skills and the ability to independently engage with a wide range of colleagues and management to gather the input and background knowledge needed to complete assignments.
Must be able to gown for entering controlled areas.
Must be able to wear specialized protective clothing wear PPE (safety shoes/glasses/etc..
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is primarily day shift Monday Friday with 24/7 support of manufacturing as quality issues arise.
Some travel may be required but expected to be minimal.
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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
