Biological Quality Manager
Hospira - Clayton, NC

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Hospira is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees.

The Hospira Clayton operation has over 300 employees and manufactures generic injectable drug products and devices. The drug products comprise of emulsion and solution products in both the small volume and large volume glass container configurations. All products manufactured at the Clayton operation are terminally sterilized

The Hospira Clayton operation has an opening for a Biological Quality Manager.

The Biological Quality Manager is responsible for overall leadership in the lab. Responsible for implementing and managing quality control systems, high standards of excellence for Good Manufacturing Practices (GMP), continuous process improvements, functional expertise, planning and forecasting to align with operational demands, management of performance metrics, employee coaching/development & staffing, and managing a team of 15.

MAJOR DUTIES AND RESPONSIBILITIES:
Oversees the BQ final product testing/release of products

Administers environmental monitoring program that is integrated into the biology/microbiology program.

Lead the laboratory in compliance with internal procedural requirements and external regulatory requirements.

Mentor, motivate and provide a continuous learning environment for a laboratory staff.

Ensures team is executing at a high level for data integrity, equipment maintenance and calibration, and successfully complying with secondary audits.

Skills/Experience Education/Certification

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Bachelors degree in Biology, Microbiology or Chemistry required with Master’s degree preferred.

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A minimum of 5 -7 years experience in a FDA regulated drug/device industries, with Quality Control experience required

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3-5 years of supervisory experience required

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Ability to manage multiple priorities

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Excellent interpersonal skills

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Excellent verbal and written communication skills with the ability to prepare and make formal presentations at the senior manager level

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Experience with QMS systems a plus

Hospira - 20 months ago - save job - block
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About this company
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Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...