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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 quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As an associate, your focus on the job will contribute in 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
CORE JOB DUTIES:
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Performs duties with the guidance of Sr. Associates
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Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance
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Support Transfer Master Cell Banks to Manufacturing
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Perform housekeeping and GMP walkthroughs of facility
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Initiate deviations in real time and assists in investigations
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Work in cross functional teams to meet and exceed timelines
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Execute or review room and line clearances
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Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedure
ADDITIONAL RESPONSIBILITIES
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Support/initiate analytical test results initial investigation on the floor
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Reviews and may approve manufacturing analytical testing on the floor
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Uses analytical skills to help ensure shop floor compliance to internal standards and procedures
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Draft and review Standard Operating Procedures
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Work independently and with minimal supervision
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Provides excellent communication
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Perform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations.
Qualifications
Must-Have
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High School Diploma (or Equivalent) and 6 years of relevant experience OR an Associate's degree in microbiology, chemistry, biological sciences, bioengineering (preferred) with 4 years of experience OR a Bachelor's degree in microbiology, chemistry, biological sciences, bioengineering (preferred) with 0+ years of experience.
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Experience in Quality Assurance in GMP facilities, drug substance, batch record review, housekeeping monitoring, GMP document review and/or creation, reviewing deviation reports, change controls, CAPA, and analytical data, or Data Integrity
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Knowledge of and experience in GMP, following applicable regulations, or willingness to become GMP proficient.
Physical / Mental requirements
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Stand/walk during entire length of shift, sit for 2 to 3 hours at a time.
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Frequently lift and or move objects up to 30 pounds.
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Use arms, hands, and fingers to handle, feel or reach.
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Ability to climb, balance, stoop, kneel, crouch, or crawl.
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Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.
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Gowning is a requirement of this position as is the use of other PPE.
Non-Standard work schedule, travel or environment requirements
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Be able to work regular business hours or shift schedule including overtime as needed.
Other job details
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Last day to appy: August 29th, 2023
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Employee Referral Bonus eligible
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 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.
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