Quality Assurance Tech II; Maryland Heights, MO
Covidien - Missouri

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Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit http://www.covidien.com to learn more about our business.

Founded as Mallinckrodt in 1867, the $2 billion Covidien pharmaceutical segment is in the process of spinning off into a separate business. This creates exciting opportunities to grow your career within an established organization that is soon to be an independent public company. Currently, the Company expects that the spinoff process will be completed in mid-2013. While we are undergoing the process, the pharmaceuticals business remains a segment of Covidien, and will continue to operate according to the Company’s strategic plan, focusing on our customers and patients who rely on our products. Equally important, pharmaceuticals’ mission remains the same: To make diagnostics and medicines better and safer for you and your family.

Perform assigned quality control or quality assurance activities in order to comply with applicable SOP's and cGMPs.

Responsible for the thorough and efficient review of completed batch record documentation ensuring adherence to Good Documentation Practices/cGMPs and applicable local procedures.
Responsible for performing Quality Assurance On The Floor tasks including line clearances, providing AQL inspections, and performing room releases for manufacturing areas.
Tasked with verifying product is acceptable for release/use through an all-inclusive documentation review and cross reference of electronic quality systems.
Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s.
Ensure the maintenance of their department, premises and equipment.
Ensure that all necessary testing is carried out to perform all the assigned tasks
confidently and consistently.

Perform all work in compliance with site safety and radiation protection guidelines.
Collaborate with other team members to ensure the quality task is performed in timely manner.
Must demonstrate flexibility in adjusting to changing priorities and schedules.
Attend mandatory trainings as required by site regulatory requirements and management.
Assist with quality investigations in order to determine root cause and applicable CAPAs.
Perform other general duties associated with the position as required by supervision.

Other duties as assigned with or without accommodation

Associate’s Degree or completion of 4 college-level life science courses required.

0 - 2 year/s of general quality/production experience in a cGMP facility.

Attention to detail. Good interpersonal skills. Good hands on, analytical, and problem solving and decision making skills Excellent writing and verbal communications skills. Good computer skills, including utilizing personal computers and data entry programs. Ability to work independently and with others to accomplish goals and priorities. Flexibility and teamwork skills. High level of energy and regular, consistent attendance.

Has consistent contact with all internal quality, distribution, QC, and production personnel. Will also have frequent interactions with colleagues and supervision.

Willingness to work in a team based environment. Close attention to detail required. May be required to sit or stand for long periods of time while performing duties. Must be able to work outside of regular work hours including weekends, holidays and overtime as needed.

Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Covidien - 17 months ago - save job - block
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Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers...