Company: Kelly Services
Posted on: July 15, 2019
Follows investigation and audit procedures, participates in
investigations (Internal as well as external) and routs associated
files for approvals, reviews and files applicable investigation
document appropriately. Log all applicable investigations records
and perform data entry in applicable reports and develop graphs of
- Provides support during internal or external investigation
performed on site.
- Supports the updating and managing of audit process and
- Initiates documentation associated with Investigation and CAPA
- Assign numbers to Investigation and CAPA records.
- Routes investigations for review, approval, and
- Track status of Investigation, CAPA, and follow-up with owners
to assure timely actions and completion.
- Communicates closure of investigation and CAPAs to
- Follow Investigation and CAPA procedures in order to monitor
and trend investigation data.
- Log and data entry of Investigation and CAPA
- Develop and distribute Investigation and CAPA report on a
- Develop and distribute reports and graphs as requested for
- Experience developing reports and creating investigation
- Works as a member of a team to achieve all outcomes;
- Operates in accordance with our Code of Conduct and Business
Ethics, and all established regulatory, compliance and safety
- Performs all work in support of our Values: Collaboration,
Courage, Perseverance, and Passion.
- Other duties as assigned by the manager.
o Associate Degree in Science, Business Administration or
Healthcare Administration with 0 - 2 years of experience, or high
school diploma with 3 - 4 years of experience with cGMP, CAPA,
investigation process and regulated pharmaceutical/medical device
- Knowledge, Skills and Abilities
o Strong knowledge of personal computer and databases such as MS
Office, Word, Excel, and Power point.
o Experience Working with cGMP procedures in a Pharmaceutical and
or Combination Device manufacturing facility.
o Experience managing investigation, CAPA process and writing
o Demonstrated ability of having cross functional / team
o Communicates well.
o Demonstrated Technical writing skills.
o Ability to understand and follow operating procedures, in order
to perform data entry and develop reports.
o Must be able to effectively present information and respond to
questions from management and/or peers.
o Must be able to read, write, and speak English proficiently.
o Ability to read, creates, and interprets charts.
o Ability to apply concepts such as fractions, percentages, ratios,
and proportions to practical situations.
o Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
o Quality Assurance experience in the pharmaceutical or other
regulated industry is required.
Why Kelly®?At Kelly
Services®, we work with the best. Our clients include 95 of the
100™ companies, and more than 70,000 hiring managers rely on Kelly
annually to access
the best talent to drive their business forward. If you only make
one career connection today, connect
Kelly Services®As a workforce advocate for over 70 years, we are
proud to directly employ nearly 500,000 people
around the world and have a role in connecting thousands more with
work through our global network of
talent suppliers and partners. Revenue in 2017 was $5.4 billion.
Visit kellyservices.com and connect with us on Facebook, LinkedIn
Kelly Services is an equal opportunity employer including, but not
limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual
Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment
is The Law.
Keywords: Kelly Services, Miami , Quality Assurance, Other , Miramar, Florida
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