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Aseptic Specialist


Kalamazoo, MI
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Job Details

The Aseptic Specialist position supports multiple Injectable aseptic operating teams that operate in Grade A,B,C, and D Classified areas (such as Filling, Manufacturing, Freeze Dry and Preparation). Develops and conducts aseptic gowning training and qualification activities for colleagues in multiple operating areas. Develops and conducts periodic audits of aseptic practices and behaviors in aseptic environments in collaboration with Operations personnel and Quality enablers. Supports the development and implementation of training programs, curricula, procedures and pertinent documents to address the skills & behaviors required to ensure that the aseptic area(s) operate in compliance.

Serves as ongoing technical resource to the aseptic operating areas, overseeing that production lots are manufactured under required aseptic behaviors and practices as well as EHS and/or GMP requirements. Provides/assists in training as necessary, presents information to large groups in some cases. Works within the site change control systems to update compliance documents. Gathers, collects, and records data. Suggests/drives improvements in systems, equipment, and processes to improve compliance and/or efficiency.

Colleague must also demonstrate proficiency in the generation and approval of training programs and documentation specific to their discipline, including SOP's, records, training documents, curricula. Ensures documentation is kept up to date and is updated within required periodic review requirements. Drives entire life cycle of document, from initial review, through updates, approval processes and implementation training as needed. Responsible for rolling out and completing all site wide training initiatives as directed by management.

Colleagues will be assigned to support aseptic areas in B41. Overtime may be required at times to support training needs.

Working Primarily Third Shift.(Weekend, Holiday, and Overtime hours may be required to meet business or customer needs).

Education: High school diploma / general education degree (GED) plus either an Associates degree or equivalent work experience (e.g. current or previous Pfizer colleague; Manufacturing, Packaging or Veterans/Military relevant experience).

Experience: Previous operations experience in aseptic work environments. Prior training experience highly desirable

**EEO Statement**

**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.

**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.

**Additional Offer Details:**

+ **Last Date to Apply for Job: November 7, 2017**

+ **Pfizer/US/Non-Exempt/Grade:** 07

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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