Quality Manager at Battelle in West Jefferson, OH

COMPANY NAME: Battelle

JOB TITLE: Quality Manager

JOB APPLY URL: http://ars2.equest.com/?response_id=9b5b4340e5a9ed652af6fd798a7fbcd2

As part of Battelle’s Health and Life Sciences Global Business, you will touch every aspect of human health. We deliver far reaching solutions to some of the world’s most pressing health challenges – from developing medical products that change individual lives to pharmaceuticals that address potentially devastating health conditions on a global scale.
Battelle supports your career by offering you the opportunity and resources to solve the most critical health problems, break through technology developments, mentorship opportunities, upward mobility, and company ethics and reputation. Are you ready to Fast Forward To Your Growth?

Our Health and Life Sciences Division is currently seeking a Quality Assurance Manager. This position located in West Jefferson, Ohio.

PRIMARY FUNCTION

To develop and implement Quality Assurance programs of assigned product line and direct the operations of the Quality Assurance staff to ensure that projects are conducted in compliance with applicable regulations, client requirements, and Battelle policies. The Quality Assurance Manager is responsible for the operation of the QA group and has authority to make work assignments, implement policies and procedures and evaluate the performance of the staff. The Quality Assurance manager reviews and approves protocols, procedures and reports to ensure that all appropriate internal and external requirements and concerns have been met. The
Quality Assurance manager reviews proposals to ascertain that sufficient funds have been allocated for QA and regulatory purposes and that the expectations of the client are being achieved.
MAJOR RESPONSIBILITIES

-Directs the activities of the Quality Assurance staff. Assigns, schedules, monitors, and reviews work and evaluates performance of assigned staff.

-Ensures quality assurance procedures, manuals and industry related regulations are developed, documented, implemented and updated, as required.

-Manages the costs of the programs to ensure they are within budget. Communicates variances and concerns to Program Manager and recommends actions, when necessary.

-Coordinates all audits and inspections performed by clients and/or regulatory agencies interacting with outside auditors and inspectors, as necessary.

-Reviews research study audits and reports to ensure program requirements are being followed. Prepares written reports to management and directors/project managers regarding the findings. Determines if needed appropriate corrective actions are taken.

-Reviews program proposals to ensure the Quality Assurance protocols are well defined, and cost estimates are reasonable to increase the probability of Battelle being granted the contract by the client.

-Writes Quality Assurance Plans (QAP) or provides QA input on proposals as requested.

-Develops training programs and trains Quality Assurance staff and external subcontractors to ensure compliance with all QA issues for the client.

-Maintains a thorough knowledge of all QA regulations and Battelle policies and attends corporate quality committee meetings.


MINIMUM JOB REQUIREMENTS

-Requires a Bachelors of Science degree, with emphasis in Biology, Chemistry, Physics and Math or equivalent.
-Requires five to ten years of experience in a quality assurance program and proven communication skills.
-Preference will be given to candidates who are certified in a professional quality organization, such as Registered Quality Assurance Professional in the Good Laboratory Practices.

For more information about our other openings, please visit www.battelle.org/careers.