QA Associate - 2nd Shift Job at Pfizer
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
You will be a member of Pfizer’s dedicated and highly effective Manufacturing Quality Assurance operations team. You will evaluate and review manufacturing activities in support of clinical and commercial batch production. Your expertise will help in identifying deviations from established standards, in the manufacturing of clinical and commercial batches. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.
As a QA Associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
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Demonstrate sufficient depth of knowledge within your own work area to perform hands-on routine QA tasks.
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Exercise judgement in resolving level appropriate quality issues related to product manufacture and testing with guidance and coaching.
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Contribute to Quality Assurance activities by undertaking a variety of level appropriate assignments. You will perform end to end assignments within Manufacturing Quality Assurance. The assignments include batch record review to include in-process batch record review/QA-on-the-floor activities.
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Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
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Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
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Maintain inspection readiness, support inspections from regulatory and improve quality assurance systems.
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Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations.
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Use established QA procedures and methodologies to propose solutions for straight forward problems with guidance and coaching.
Qualifications
Must-Have
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Six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.
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Experience in Quality administered systems.
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Sound knowledge of current Good Manufacturing Practices.
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Ability to work in a team environment within own team and interdepartmental teams.
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Good written and oral communication skills.
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Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.
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Effectively manages stressful situations, able to focus on task regardless of circumstances and stress induced pressure.
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Good collaboration, relationship management and interpersonal skills.
Nice-to-Have
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Field of study in Biology, Chemistry, Engineering or related Technical Physical Science.
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Experience at a manufacturing site.
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Experience of writing and managing deviations.
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Experience in production batch record review and change control management.
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Experience with SAP, LIMS, QTS.
PHYSICAL/MENTAL REQUIREMENTS
Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting
where sitting and computer usage would be the norm.
where sitting and computer usage would be the norm.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a second shift position to support manufacturing operations .
Limited travel for the position; no more than 5% traveling. It will be necessary to work in areas that require
aseptic gowning.
Limited travel for the position; no more than 5% traveling. It will be necessary to work in areas that require
aseptic gowning.
Work Location Assignment: On Premise
Last Date to Apply for Job: December 6, 2022
Eligible for Relocation Package: No
Eligible for Relocation Package: No
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
Please Note :
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