Senior Quality Testing Engineer - Des Moines, United States - Curium Pharma

Description

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Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually.

The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine.

The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve:
An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position

The Senior Quality Control Testing Engineer provides technical counsel concerning the scientific content of methods, analytical testing, instrumentation, evaluation and interpretation of laboratory data, assisting in OOS investigations, and other QC related issues as required.

Essential Functions

Perform Preventative Maintenance and Demand Maintenance on QC instruments and equipment
Author and execute analytical method, and equipment/instrument IQ/OQ/PQ protocols.
Coordinate with external contractors to facilitate instrument maintenance and repairs
Author Standard Operating Procedures for new instruments/software
While working in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, Health Canada, OSHA, etc.)
Author Change Controls, Protocols, Corrective and Preventive Action items and Periodic Reviews.
Assure compliance with department training and qualification.

Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.

Authors Change Controls in Quality Management systems.
Assists in training of laboratory personnel
Perform routine testing to support the release of finished product, raw materials, API as needed
Requirements

Bachelor of Science Degree in Chemistry, or other science related field, preferred.
5 or more years of relevant experience in a cGMP environment required.
Extensive knowledge of laboratory instruments/methods such as HPLC, GC, IC, ICP, FTIR, UV, wet bench methods, etc.

Preferred Experience:
Lean Leader/Operational Excellence/5S
Root Cause Analysis tools (Fishbone, 5 Why, Is/Is Not, etc.)

Working Conditions:

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

Must be able to wear a variety of personal protective equipment.
Able to work in a team-based environment across all functional groups.
Close attention to detail required, must possess good hand-eye coordination.
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.
Able to remain calm in emergency situations while directing other employees
Ability to follow procedures and enforce compliance with procedures

Responsibilities also include the ability to lift (up to 70lbs), walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.

Disclaimer

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.

Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Segment:
QA Tester, Medical Technologist, Quality Engineer, Compliance, QC, Quality, Healthcare, Engineering, Legal

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