SlideShare a Scribd company logo
PharmSci QA Summer Student Worker 2015
Tyla Mahon
Andover, MA
ABSTRACT
My name is Tyla Mahon and I will be a senior this
upcoming fall at Southern New Hampshire University
(SNHU). At SNHU, I was selected to be part of an
integrated business program called Degree in Three. I was
included in the pilot group of students that SNHU has
welcomed to the program. It is an unique experience
because the program is solely business orientated,
incorporating all of the core curriculum into the major
classes, allowing us to graduate with all of the collegiate
requirements met in just three years rather than the
standard four year Bachelor’s degree.
I have always admired what Pfizer has stood for and it
gave me a great interest in the industry. During my second
year at SNHU I learned of the opportunities Pfizer offers
for students and I applied for a Summer Student Worker
position for the 2015 summer. I then was chosen to
support the Pfizer Andover, PharmSci QA group under the
management of Denise Gleich.
It has truly been an honor to be a part of Pfizer
Andover’s team this summer. Not only have I enjoyed
every day of it, but I have learned more than I could’ve
imagined. The opportunities that I have experienced have
served to educate me on working in a large corporation,
but has also exposed me to experiences and networking
that I would never have imagined.
Internal Audits
With Theresa McCarthy
• While working with Theresa I got to experience a side
of the company that many people do not. Internal
Auditing is a crucial part of Pfizer. Auditors ensure that
employees have the required training to perform their
job. In addition, auditors verify that the procedures
employees use to meet the requirements of board of
health around the world where Pfizer sells their
products (e.g. U.S.-FDA)
• I was able to assist Theresa in many situations such as:
preparing minutes for the Software Medical Device Site
Quality Review Team, developed the Agenda for the
Global Biotherapeutics Analytical Quality Council, and
developed an Internal Audit Plan and Checklist for
Andover Liquid Dose Manufacturing Facility
• Other activities included; posting Regulatory
Intelligence to the Compliance Intelligence Alert (CIA)
SharePoint, updating the Risk Register and mitigation
plan as well as attended the Audit Inspection
Compliance Effectiveness (AICE) Team Meeting.
AWARDS
During my time here at Pfizer I was awarded an
Andover Quality Culture Recognition Award. This
award was presented by Laura White for Recognition
of Strong Quality Culture Behavior while working on a
CAPA project to help not only Andover, but the Groton,
St. Louis, and Sandwich sites as well.
“Your resourcefulness has helped QA in Andover, St.
Louis, Groton and Sandwich to determine the
appropriate QA contact. Your collaboration has
helped QA at various locations to collaborate on this
CAPA. Thank you.” –Laura White
Key Learnings
My biggest take away from Pfizer Andover is how
essential teamwork and collaboration is. It is crucial
that Pfizer employees work as a team Lack of
communication can lead to detrimental
consequences for not only Pfizer, but to customers
across the world.
I was very lucky to be able to shadow and
experience many different positions that employees
hold here and how they all play a role in the
manufacturing of our products.
My appreciation for, not only the Pharmaceutical
Industry but for, business itself has grown
immensely. As a business major, I have seen
firsthand how safety, teamwork and integrity can
affect a company and I am beyond grateful that I
can take back to school what I have learned here at
Pfizer Andover. I now have the opportunity to share
this experience with my business studies at
Southern New Hampshire University.
Record retention, GDMS & archival of GMP
records
With Veronica Chamberland
 This summer I had the pleasure of working with Veronica
under Denise Gleich. My Primary responsibilities included
uploading scanned copies of Master Batch Records and
Manufacturing Batch Records into the Global Document
Management System (GDMS) and archiving records for
long term storage. This project was a critical aspect of
doing business here at Pfizer, because we manufacture
drug product, our records are regulated by the Food and
Drug Administration (FDA). I processed a large volume of
work in a short period of time by entering data into
spreadsheets and uploading scans, making document
retrieval easier for employees around the world going
forward.
 I also had the opportunity to spend time with the Quality
Culture Group. During which I took meeting minutes for
the Calibration Risk Exercise in Andover. I then
collaborated with all PharmSci Sites to combine all the
information from the Calibration Risk Exercise and I
published the results on the Quality Culture SharePoint
site.
PALS Tour
With Jen Sloan
 Here I helped organize and execute a student tour for the Phillip
Exeter’s Performing Artists at Lincoln School (PALS) Program.
PALS is made up of students from the Leonard and Parthum
Middle Schools in neighboring Lawrence, MA, and the goal of the
PALS program is to expose the children to special tutoring and
academics, and give them the skills and support that they need to
stay in school and attend college.
- These students are hand selected by their teachers to participate in this
two year mentoring program due to their good academic and behavioral
standing. Many of these students are the children of immigrants, and
would be the first in their families to attend college.
 I was able to assist this program by escorting a group of 12
students through the BRD lab and Pilot areas. Andover has been
providing a ½-day science related field trip to these students for
the past seven years.
WLN
Women's
Leadership
Network
Internal
Audits
GDMS
CAPA
1053880
PALS
Tour
Projects
CAPA 1053880
With Laura White
 I also had the pleasure to work on a Corrective Action
Preventative Action (CAPA) for Laura White. This
particular CAPA involved both Pharmaceutical
Therapeutics Pharmaceutical Sciences (PTx PS) and
Biological Therapeutics Pharmaceutical Sciences and
(BTx PS) products. My task was to research and review a
list of 112 product records obtained from Clinicopia. Many
of these records needed some gaps filled and more
specifically needed the description updated.
 I performed an assessment of the PTx and BTx excel
record containing the DMID numbers and the descriptions
and performed a comparison study against the product
records to identify gaps between them and then I filled all
of the gaps completing the product records. Some of the
gaps we not easily filled as many were not in either of the
data samples so I had to research and navigate through
the BTx SharePoint and Carol Bye’s SharePoint to
determine who the QA representative was for each of the
112 items. I then looked at BTx projects lead file and
found the products and filled in the representatives from
different business units.
 This process took several days, but will help many QA
representatives from different Pfizer sites for a long time
to come.
Women’s Leadership Network (WLN)
With Theresa McCarthy and Veronica Chamberland
 When working with WLN at Pfizer I was able to help by
supporting the Women’s Leadership Network Lunch and
Learn, which had an amazing attendance of over 60 people.
 I also attended monthly meetings in which we discussed
current and future WLN events for the upcoming year.

More Related Content

Similar to Summer Student Worker Poster-Tyla Mahon2

Can Bureaucratic Organizations Really Innovate?
Can Bureaucratic Organizations Really Innovate?Can Bureaucratic Organizations Really Innovate?
Can Bureaucratic Organizations Really Innovate?
Ahmad Chamy
 
Avoca Quality Consortium 2014 Summit Bio Booklet
Avoca Quality Consortium 2014 Summit Bio BookletAvoca Quality Consortium 2014 Summit Bio Booklet
Avoca Quality Consortium 2014 Summit Bio Booklet
The Avoca Group
 
Khal Sadiq - Projects, Posters and Roadshows
Khal Sadiq - Projects, Posters and RoadshowsKhal Sadiq - Projects, Posters and Roadshows
Khal Sadiq - Projects, Posters and Roadshows
Khal Sadiq
 
Supporting Statement
Supporting StatementSupporting Statement
Supporting Statement
Sharon Turner
 
Intern Final Reflection
Intern Final ReflectionIntern Final Reflection
Intern Final Reflection
Hollie Peterson
 
My Own Creative Process And Transformative Experiences...
My Own Creative Process And Transformative Experiences...My Own Creative Process And Transformative Experiences...
My Own Creative Process And Transformative Experiences...
Kristi Anderson
 
Spiritually Diverse World Nursing Discussion.pdf
Spiritually Diverse World Nursing Discussion.pdfSpiritually Diverse World Nursing Discussion.pdf
Spiritually Diverse World Nursing Discussion.pdf
bkbk37
 
Cns Interns 2014-2015
Cns Interns 2014-2015Cns Interns 2014-2015
Cns Interns 2014-2015
Elena Sharnoff
 
Iu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 Final
Iu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 FinalIu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 Final
Iu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 Final
Brad Doebbeling
 
Nursing Jones Misdiagnosis Question.pdf
Nursing Jones Misdiagnosis Question.pdfNursing Jones Misdiagnosis Question.pdf
Nursing Jones Misdiagnosis Question.pdf
bkbk37
 
SUMMIT 2013 Bio Booklet
SUMMIT 2013 Bio BookletSUMMIT 2013 Bio Booklet
SUMMIT 2013 Bio Booklet
The Avoca Group
 
RESUME UPDATED 2016 07
RESUME UPDATED 2016 07RESUME UPDATED 2016 07
RESUME UPDATED 2016 07
Eva Olivares
 
NikkiHammond_internshipreport
NikkiHammond_internshipreportNikkiHammond_internshipreport
NikkiHammond_internshipreport
Nicole Hammond
 
Curriculum Vitae-Apoorva Sharma.
Curriculum Vitae-Apoorva Sharma.Curriculum Vitae-Apoorva Sharma.
Curriculum Vitae-Apoorva Sharma.
Apoorva Sharma
 
UC Davis School of Medicine Poster Presentation, LGC 2016
UC Davis School of Medicine Poster Presentation, LGC 2016UC Davis School of Medicine Poster Presentation, LGC 2016
UC Davis School of Medicine Poster Presentation, LGC 2016
Janeet Dhauna
 
internship final paper 2015
internship final paper 2015internship final paper 2015
internship final paper 2015
Brandi Bennett
 
Evaluation Of A Nursing Career Essay
Evaluation Of A Nursing Career EssayEvaluation Of A Nursing Career Essay
Evaluation Of A Nursing Career Essay
Buy A Paper Online Clemson University
 
Examining the Impact of Accreditation on a Primary Healthcare Organization in...
Examining the Impact of Accreditation on a Primary Healthcare Organization in...Examining the Impact of Accreditation on a Primary Healthcare Organization in...
Examining the Impact of Accreditation on a Primary Healthcare Organization in...
Dr. ALIA BANNA
 
A Checklist For The Development Of Faculty Mentorship Programs
A Checklist For The Development Of Faculty Mentorship ProgramsA Checklist For The Development Of Faculty Mentorship Programs
A Checklist For The Development Of Faculty Mentorship Programs
Nathan Mathis
 
Avoca Quality Consortium Summit 2013 Bio Booklet
Avoca Quality Consortium Summit 2013 Bio BookletAvoca Quality Consortium Summit 2013 Bio Booklet
Avoca Quality Consortium Summit 2013 Bio Booklet
The Avoca Group
 

Similar to Summer Student Worker Poster-Tyla Mahon2 (20)

Can Bureaucratic Organizations Really Innovate?
Can Bureaucratic Organizations Really Innovate?Can Bureaucratic Organizations Really Innovate?
Can Bureaucratic Organizations Really Innovate?
 
Avoca Quality Consortium 2014 Summit Bio Booklet
Avoca Quality Consortium 2014 Summit Bio BookletAvoca Quality Consortium 2014 Summit Bio Booklet
Avoca Quality Consortium 2014 Summit Bio Booklet
 
Khal Sadiq - Projects, Posters and Roadshows
Khal Sadiq - Projects, Posters and RoadshowsKhal Sadiq - Projects, Posters and Roadshows
Khal Sadiq - Projects, Posters and Roadshows
 
Supporting Statement
Supporting StatementSupporting Statement
Supporting Statement
 
Intern Final Reflection
Intern Final ReflectionIntern Final Reflection
Intern Final Reflection
 
My Own Creative Process And Transformative Experiences...
My Own Creative Process And Transformative Experiences...My Own Creative Process And Transformative Experiences...
My Own Creative Process And Transformative Experiences...
 
Spiritually Diverse World Nursing Discussion.pdf
Spiritually Diverse World Nursing Discussion.pdfSpiritually Diverse World Nursing Discussion.pdf
Spiritually Diverse World Nursing Discussion.pdf
 
Cns Interns 2014-2015
Cns Interns 2014-2015Cns Interns 2014-2015
Cns Interns 2014-2015
 
Iu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 Final
Iu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 FinalIu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 Final
Iu Ahrq Hai Assessment Ctr Presentation Feb 22 2010 Final
 
Nursing Jones Misdiagnosis Question.pdf
Nursing Jones Misdiagnosis Question.pdfNursing Jones Misdiagnosis Question.pdf
Nursing Jones Misdiagnosis Question.pdf
 
SUMMIT 2013 Bio Booklet
SUMMIT 2013 Bio BookletSUMMIT 2013 Bio Booklet
SUMMIT 2013 Bio Booklet
 
RESUME UPDATED 2016 07
RESUME UPDATED 2016 07RESUME UPDATED 2016 07
RESUME UPDATED 2016 07
 
NikkiHammond_internshipreport
NikkiHammond_internshipreportNikkiHammond_internshipreport
NikkiHammond_internshipreport
 
Curriculum Vitae-Apoorva Sharma.
Curriculum Vitae-Apoorva Sharma.Curriculum Vitae-Apoorva Sharma.
Curriculum Vitae-Apoorva Sharma.
 
UC Davis School of Medicine Poster Presentation, LGC 2016
UC Davis School of Medicine Poster Presentation, LGC 2016UC Davis School of Medicine Poster Presentation, LGC 2016
UC Davis School of Medicine Poster Presentation, LGC 2016
 
internship final paper 2015
internship final paper 2015internship final paper 2015
internship final paper 2015
 
Evaluation Of A Nursing Career Essay
Evaluation Of A Nursing Career EssayEvaluation Of A Nursing Career Essay
Evaluation Of A Nursing Career Essay
 
Examining the Impact of Accreditation on a Primary Healthcare Organization in...
Examining the Impact of Accreditation on a Primary Healthcare Organization in...Examining the Impact of Accreditation on a Primary Healthcare Organization in...
Examining the Impact of Accreditation on a Primary Healthcare Organization in...
 
A Checklist For The Development Of Faculty Mentorship Programs
A Checklist For The Development Of Faculty Mentorship ProgramsA Checklist For The Development Of Faculty Mentorship Programs
A Checklist For The Development Of Faculty Mentorship Programs
 
Avoca Quality Consortium Summit 2013 Bio Booklet
Avoca Quality Consortium Summit 2013 Bio BookletAvoca Quality Consortium Summit 2013 Bio Booklet
Avoca Quality Consortium Summit 2013 Bio Booklet
 

Summer Student Worker Poster-Tyla Mahon2

  • 1. PharmSci QA Summer Student Worker 2015 Tyla Mahon Andover, MA ABSTRACT My name is Tyla Mahon and I will be a senior this upcoming fall at Southern New Hampshire University (SNHU). At SNHU, I was selected to be part of an integrated business program called Degree in Three. I was included in the pilot group of students that SNHU has welcomed to the program. It is an unique experience because the program is solely business orientated, incorporating all of the core curriculum into the major classes, allowing us to graduate with all of the collegiate requirements met in just three years rather than the standard four year Bachelor’s degree. I have always admired what Pfizer has stood for and it gave me a great interest in the industry. During my second year at SNHU I learned of the opportunities Pfizer offers for students and I applied for a Summer Student Worker position for the 2015 summer. I then was chosen to support the Pfizer Andover, PharmSci QA group under the management of Denise Gleich. It has truly been an honor to be a part of Pfizer Andover’s team this summer. Not only have I enjoyed every day of it, but I have learned more than I could’ve imagined. The opportunities that I have experienced have served to educate me on working in a large corporation, but has also exposed me to experiences and networking that I would never have imagined. Internal Audits With Theresa McCarthy • While working with Theresa I got to experience a side of the company that many people do not. Internal Auditing is a crucial part of Pfizer. Auditors ensure that employees have the required training to perform their job. In addition, auditors verify that the procedures employees use to meet the requirements of board of health around the world where Pfizer sells their products (e.g. U.S.-FDA) • I was able to assist Theresa in many situations such as: preparing minutes for the Software Medical Device Site Quality Review Team, developed the Agenda for the Global Biotherapeutics Analytical Quality Council, and developed an Internal Audit Plan and Checklist for Andover Liquid Dose Manufacturing Facility • Other activities included; posting Regulatory Intelligence to the Compliance Intelligence Alert (CIA) SharePoint, updating the Risk Register and mitigation plan as well as attended the Audit Inspection Compliance Effectiveness (AICE) Team Meeting. AWARDS During my time here at Pfizer I was awarded an Andover Quality Culture Recognition Award. This award was presented by Laura White for Recognition of Strong Quality Culture Behavior while working on a CAPA project to help not only Andover, but the Groton, St. Louis, and Sandwich sites as well. “Your resourcefulness has helped QA in Andover, St. Louis, Groton and Sandwich to determine the appropriate QA contact. Your collaboration has helped QA at various locations to collaborate on this CAPA. Thank you.” –Laura White Key Learnings My biggest take away from Pfizer Andover is how essential teamwork and collaboration is. It is crucial that Pfizer employees work as a team Lack of communication can lead to detrimental consequences for not only Pfizer, but to customers across the world. I was very lucky to be able to shadow and experience many different positions that employees hold here and how they all play a role in the manufacturing of our products. My appreciation for, not only the Pharmaceutical Industry but for, business itself has grown immensely. As a business major, I have seen firsthand how safety, teamwork and integrity can affect a company and I am beyond grateful that I can take back to school what I have learned here at Pfizer Andover. I now have the opportunity to share this experience with my business studies at Southern New Hampshire University. Record retention, GDMS & archival of GMP records With Veronica Chamberland  This summer I had the pleasure of working with Veronica under Denise Gleich. My Primary responsibilities included uploading scanned copies of Master Batch Records and Manufacturing Batch Records into the Global Document Management System (GDMS) and archiving records for long term storage. This project was a critical aspect of doing business here at Pfizer, because we manufacture drug product, our records are regulated by the Food and Drug Administration (FDA). I processed a large volume of work in a short period of time by entering data into spreadsheets and uploading scans, making document retrieval easier for employees around the world going forward.  I also had the opportunity to spend time with the Quality Culture Group. During which I took meeting minutes for the Calibration Risk Exercise in Andover. I then collaborated with all PharmSci Sites to combine all the information from the Calibration Risk Exercise and I published the results on the Quality Culture SharePoint site. PALS Tour With Jen Sloan  Here I helped organize and execute a student tour for the Phillip Exeter’s Performing Artists at Lincoln School (PALS) Program. PALS is made up of students from the Leonard and Parthum Middle Schools in neighboring Lawrence, MA, and the goal of the PALS program is to expose the children to special tutoring and academics, and give them the skills and support that they need to stay in school and attend college. - These students are hand selected by their teachers to participate in this two year mentoring program due to their good academic and behavioral standing. Many of these students are the children of immigrants, and would be the first in their families to attend college.  I was able to assist this program by escorting a group of 12 students through the BRD lab and Pilot areas. Andover has been providing a ½-day science related field trip to these students for the past seven years. WLN Women's Leadership Network Internal Audits GDMS CAPA 1053880 PALS Tour Projects CAPA 1053880 With Laura White  I also had the pleasure to work on a Corrective Action Preventative Action (CAPA) for Laura White. This particular CAPA involved both Pharmaceutical Therapeutics Pharmaceutical Sciences (PTx PS) and Biological Therapeutics Pharmaceutical Sciences and (BTx PS) products. My task was to research and review a list of 112 product records obtained from Clinicopia. Many of these records needed some gaps filled and more specifically needed the description updated.  I performed an assessment of the PTx and BTx excel record containing the DMID numbers and the descriptions and performed a comparison study against the product records to identify gaps between them and then I filled all of the gaps completing the product records. Some of the gaps we not easily filled as many were not in either of the data samples so I had to research and navigate through the BTx SharePoint and Carol Bye’s SharePoint to determine who the QA representative was for each of the 112 items. I then looked at BTx projects lead file and found the products and filled in the representatives from different business units.  This process took several days, but will help many QA representatives from different Pfizer sites for a long time to come. Women’s Leadership Network (WLN) With Theresa McCarthy and Veronica Chamberland  When working with WLN at Pfizer I was able to help by supporting the Women’s Leadership Network Lunch and Learn, which had an amazing attendance of over 60 people.  I also attended monthly meetings in which we discussed current and future WLN events for the upcoming year.