CAPA Specialist - Processing (2nd Shift) $3k Sign-on Bonus
Company: Abbott Laboratories
Location: Warsaw
Posted on: August 4, 2022
Job Description:
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.Nourish the world and your
career as part of the Nutrition team at Abbott.Our Nutrition
business develops science-based nutrition products for people of
all ages, from helping babies and children grow, to keeping adult
bodies strong and active. Millions of people around the world count
on our leading brands - including Similac -, PediaSure -, Pedialyte
-, Ensure -, Glucerna - and ZonePerfect - - to help get the
nutrients they need to live their healthiest life.WHAT WE OFFER At
Abbott, you can have a good job that can grow into a great career.
We offer:
- Fast paced work environment where your safety is our
priority
- Production areas that are clean, well-lit and
temperature-controlled
- Training and career development, with onboarding programs for
new employees and tuition assistance
- Financial security through competitive compensation, incentives
and retirement plans
- Health care and well-being programs including medical, dental,
vision, wellness and occupational health programs, Medical Benefits
start day 1
- Vacation - 3 weeks accrued vacation (1st year is prorated) +
vacation buy program + 3 personal days + 10 paid holidays
- Company Paid Pension Plan
- 401(k) retirement savings with a generous company match of
5%
- The stability of a company with a record of strong financial
performance and history of being actively involved in local
communitiesLearn more about our benefits that add real value to
your life to help you live fully: WHAT YOU'LL DO Progresses
investigations through the CAPA system in support of non-CAPA
organizations. Works closely with other functional areas with the
use of investigational tools, to determine the root cause of any
nonconformity, ensure that CAPA plans address root causes, and
ensure that CA/PAs are implemented to facilitate the rapid,
compliant, introduction of new/improved products, processes, and
systems. Works to ensure that actions are on time, thorough,
complete, meet the needs of the business and customers, and that
required standards and/or procedural requirements are met. Is an
effective member of a multifunctional team, ensuring that all
communications, interpersonal interactions and business behaviors
are consistent with the Abbott Code of Conduct. MAIN
RESPONSIBILITIES Evaluates and progress the timely completion of
CAPA system activities, including effectiveness checks, raised for
non-conformances, potential non-conformances, and/or deviations, as
output from the division's Quality System. Facilitates the
investigation process to ensure that root/potential causes are
appropriate and implement effective actions to reduce the
occurrence/recurrence of the nonconformance. Maintains the
effectiveness of the CAPA system records to ensure audit-readiness
for internal and external quality system audits within the area.
Ensure all CAPA-related documentation is managed in a complete,
clear, concise, and controlled manner. Supports a work environment
that ensures team effectiveness by demonstrating full cross
functional team support that complies with Corporate and regulatory
requirements. Supports the attainment of division goals and
objectives. Accountable to the Quality Organization for achieving
mutually agreed upon objectives. Supports other organizations in
the management of their CAPA actions and provide additional
confidence that investigations are initiated and completed in a
complete, concise, and timely manner; and that viable corrective
actions are identified and implemented to address any
non-conformances. The CAPA System is a key inspection focus of
worldwide regulators and auditors. The system must be usable,
simple, sustainable and well maintained. Failure to comply with the
primary objectives of this role can result in negative impact to
the business such as observations, warning letters,
de-certification, or product recalls. Decisions and recommendations
made by this position impact quality decisions for marketed
products and the division's Quality System. QUALIFICATIONS
Education Education Level minimumAssociates Degree ( - 13
years)orBachelors Degree ( - 16 years)Preferred
Experience/Background Minimum 2 yearsMinimum of two (2) years of
experience working in a regulated environment or experience
performing investigations. Knowledge of FDA Quality System
Regulations (QSR) and/or ISO13485 is preferred.Able to apply
strategic and quality logic and project management skills to
investigation activities ensuring appropriate investigations are
conducted.Good project management skills to deliver an effective
service in a timely manner.Attention to detail to ensure accuracy
of work that forms part of the Quality System documentation.Good
written and oral communication skills to ensure effective and
succinct report generation, and effective communication with staff
at all levels of the organization.Able to work independently..
Keywords: Abbott Laboratories, South Bend , CAPA Specialist - Processing (2nd Shift) $3k Sign-on Bonus, Other , Warsaw, Indiana
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