Principal Quality Assurance Technician
Company: Curium
Location: Maryland Heights
Posted on: May 28, 2023
Job Description:
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 Perform and be responsible for Quality
Assurance activities in order to comply with applicable SOP's and
cGMPs. Will coordinate and oversee the work of others. Work under
limited supervision with considerable latitude for the +use of
initiative and independent judgment. Ability to manage projects
using cross-functional teams. Work schedule: Saturday - Tuesday
7:00 PM - 5:30 AM Essential Functions
- Ensure completion of required training, work (including
document review, batch release, QA on-the-floor, AQLs), and timely
release of materials and batches.
- Responsible for the thorough and efficient review and
disposition of completed batch record documentation ensuring
adherence to Good Documentation Practices/cGMPs and applicable
local procedures.
- Responsible for performing and/ or overseeing performance of
Quality Assurance on the floor tasks including but not limited to
performing AQL inspections, performing clearances for manufacturing
areas and providing Quality input and guidance to manufacturing
personnel.
- Responsible for dispositioning finished product, raw materials/
components and intermediates through an all-inclusive documentation
review and cross reference of electronic quality systems.
- Responsible with release of incoming raw materials and
components per applicable local procedures. This may include
support for labeling dispositioned raw materials and components
with appropriate status indicator labels.
- Ensure a safe and quality working environment through training,
awareness, and compliance to safety/Quality guidelines and
SOP's.
- Ensure the maintenance of department, premises and
equipment.
- Ensure that all assigned training is carried out to competently
perform assigned tasks confidently and consistently.
- Perform all work in compliance with site safety and radiation
protection guidelines.
- Collaborate with other team members to ensure assigned tasks
are performed in a timely manner.
- Must demonstrate flexibility in adjusting to changing
priorities and schedules.
- Attend mandatory trainings as required by site regulatory
requirements and management.
- Perform other general duties associated with the position as
required by supervision. Requirements
- Bachelor's degree preferred in life science or a related field;
or equivalent experience.
- 6 or more years of relevant quality/quality control/production
experience in a cGMP facility.
- Excellent attention to detail skillset.
- Experience with computer data entry required. Proficient in use
of Microsoft suite office products.
- Strong communication, organization and time management skills
are necessary.
- Ability to communicate professionally, knowledgeably and
efficiently.
- Strong problem solving, decision making, verbal and written
communications skills are necessary.
- Leadership skills including but not limited to mentoring,
assignments of work flows, personnel development, personnel
performance management.
- Must be able to analyze causes of interpersonal conflict and
resolve complex communication issues (i.e., undefined roles,
objectives and information gaps).
- Must be able to resolve problems, handle conflict and make
effective decisions under pressure. Excellent writing and verbal
communications skills.
- Ability to give, receive, and analyze information, formulate
work plans, prepare written materials and articulate goals and
action plans.
- Action oriented/drives for results. Ability to multitask
projects that support personal and site goals.
- Ability to communicate professionally, knowledgeably and
efficiently.
- Excellent writing and verbal communications skills.
- Ability to do simple to complex math calculations, input data
into the computer and analyze data as required.
- Ability to work independently and as part of a team.
- Ability to plan, prioritize and delegate daily QA Release job
tasks.
- Ability to identify and drive implementation of initiatives to
meet or exceed departmental metrics and goals. Working conditions:
- 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 and overtime as needed.
- Willingness to support Manufacturing operations as Quality
on-the-floor. This may require specialized gowning and associated
qualifications required for the area.
- 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.
- Must be able to work outside of regular work hours.
- Responsibilities also include the ability to lift, walk, bend,
stoop, push, pull, reach, and climb stairs with or without
accommodation.
- Must possess good hand-eye coordination.
Keywords: Curium, Springfield , Principal Quality Assurance Technician, Professions , Maryland Heights, Illinois
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