Contractor) Senior Operations Quality Engineer
Company: Curium Pharma
Posted on: April 5, 2021
(Contractor) Senior Operations Quality Engineer Date: Jan 18,
2021 Location: Noblesville, IN, United States About Curium 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 position is responsible
for enforcing and supporting the Quality Management System (QMS) in
accordance with Company policies and procedures. The position will
be responsible for providing confidence to management that product
quality requirements will and have been met.-- Essential
- Cross functional cGMP collaboration with Engineering, R&D,
Chemistry, Compliance, and Production team members.
- Create, revise, and review cGMP Quality policies and
- Initiate, review, and monitor Quality Events (DEV, CAPA, CC,
- Provide initial GMP and Annual Refresher GMP Training.
- Review GMP protocols and reports.
- May participate in regulatory and client audits.
- Performs internal GMP audits.
- Conduct Laboratory Walk-Thru Audits.
- Provide On-The-Floor Production Support, as needed.
- Track and report KPP and Quality metrics.
- Analyze data to identify areas for improvement in the quality
system (GMP QMS). Act as 2nd person verifier during production
- Assist in compiling and evaluating data for the Annual Product
Review Report Requirements
- Bachelor Degree in Life Sciences or Engineering.
- Minimum of 5-8 years of Quality experience in a pharmaceutical
- Significant experience investigating exceptions and other
variances, using Quality Engineering Tools and Techniques (i.e. RCA
tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot,
Kepnor-Tregoe, Comparative Analysis)
- Must be thoroughly familiar with applicable regulatory
guidelines concerning the establishment, validation, and
documentation of test procedures, equipment, processes and facility
- Working knowledge of cGMP guidelines and their application in a
controlled aseptic environment is strongly preferred.
- Must be able to work with other groups to seek understanding
and resolve issues, close gaps, and seek compliant out comes.
- Must have experience with statistical tools. Certification in
Lean or Six Sigma preferred-- Working Conditions
- Standard office environment, coupled with approximately 25%
time in clean room, radiopharmaceutical manufacturing, and
- Must be willing to wear a variety of personal protective
- 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.
- Responsibilities also include the ability to sit, stand, walk,
bend, push, pull, reach, and climb stairs without
- May be required to sit or stand for long periods of time while
performing duties. 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: Operations Manager, Quality Engineer, Consulting,
Engineering, Operations, Quality, Service
Keywords: Curium Pharma, Noblesville , Contractor) Senior Operations Quality Engineer, Engineering , Noblesville, Indiana
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