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Aseptic Compliance Supervisor, Day Shift


Rocky Mount, NC
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Job Details

The Aseptic Compliance Supervisor is responsible for supervision of the Aseptic Environmental Cleaning Specialist and serves as a leader to the Aseptic core monitors. This leadership position helps to insure continuous compliance with cGMPs and aseptic technique.

Supervise the work activities of Aseptic Environmental Cleaning Specialist.

Responds to planned events (such as shutdown) or unplanned events resulting in non-aseptic conditions and coordinates activities to return the corridor to an aseptic state.

Provides corrective action when necessary.

Identify and implement CAPAs related to departmental process improvements.

Assists in planning and oversight of media fill simulations including review and publishing of related documentation.

Serves as a leader for the Aseptic Core Monitor.

Works closely with the training department to ensure Aseptic certified employees are compliant with cGMP's and trained on appropriate procedures.

Complies with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.

Other duties as they relate to the position.

Perform other related duties as assigned or required.

BS/BA degree in Business or in a technical (engineering) related field required.

Strongly Preferred, 3 years manufacturing experience preferably in an FDA industry.

Requires 2-3 years supervisory experience or equivalent leadership and/or coordinator experience.

Aseptic Clean Room Certification preferred

Equivalent combination of education, certifications and experience will be considered in lieu of a 2 or 4 year degree at the discretion of Hospira management.

Must be able to exercise leadership, diplomacy, and problem solving skills when coordinating and working with all levels of employees.

Must have the ability to successfully complete project commitments.

Physical/ Mental Requirements

Ability to gown and enter aseptic areas, walk, climb stairs, work on knees occasionally, respond to visual warning indicators, respond to audible warning indicators, work with biological materials, work with chemicals, wear specialized protective clothing (type: bunny suits) Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis. 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.

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.

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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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