Use Your Power for Purpose
Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizers mission. You will play a crucial role in improving patients lives by ensuring that our team is well-trained and compliant with Good Manufacturing Practices (GMP). Your efforts ensure that patients and physicians have timely access to the medicines they need.
What You Will Achieve
In this role you will:
Responsible for owning and implementing CAPAs for the Aseptic Compliance and Training department
Develop and implement curricula procedures and pertinent documents to address the skills and behaviors required to ensure that the sterile manufacturing areas(s) operate in compliance
Maintain working knowledge of Good Manufacturing Practicesand emerging regulatory and compliance concerns.
Provide recommendations for improvementsin the sterile manufacturing training program trainingsregularly in order to ensure Continuous Improvement loop.
Deliver EM training to all EM analysts including sampling of production areas and processing of utility samples environmental samples and commodities.
Deliver training on the appropriate use of EM equipment and SOPs. Aseptic technique will be utilized for sample collection as required per standard operating procedures.
Deliver sterile manufacturing training to all new colleagues/continent workers and current operations colleagues (when required). Train all operations colleagues annually on sterile manufacturing refresher training.
Maintain accurate complete and legible records. May utilize Laboratory Information Management Systems (LIMS) Mobile Data Acquisition (MODA) or other electronic record systems.
Complies with all Safety Environmental and Security policies as required. Communicate all safety concerns incidents and events as they occur.
Here Is What You Need (Minimum Requirements):
BA/BS degree with any years of experience or Associates degree with 4 years of experience or high school diploma (or equivalent) with 6 years of relevant experience
Excellent communication skills both oral and written
Solid understanding of GMP and Regulatory Training compliance
Experience in Technical Training Skills
Proficiency in MS Office especially Word and PowerPoint
Strong organizational and time management skills
Bonus Points If You Have(Preferred Requirements):
A solid understanding of manufacturing processes and regulatory compliance
Strong problem-solving skills and attention to detail
Ability to adapt to changing priorities and manage multiple tasks
Experience in developing and delivering training programs
Strong interpersonal skills and the ability to work effectively with diverse teams
Demonstrated ability to lead and mentor others
PHYSICAL/MENTAL REQUIREMENTS
Ability to work in fast past high pressure environment. Be able to be on your feet for extended periods while conducting trainings sessions.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to work nonstandard hours/shifts to meet business needs.
Other Job Details:
Last day to apply: February 4th
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 E-Verify employer. This position requires permanent work authorization in the United States.
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Required Experience:
IC
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